Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2023 – 31.03.2023 Німеччина

Німеччина

 

https://www.bfarm.de/EN/Medical-devices/Tasks/Risk-assessment-and-research/Field-corrective-actions/_node.html

https://www.bfarm.de/SharedDocs/Kundeninfos/DE/10/2022/29316-21_kundeninfo_de.pdf?__blob=publicationFile

Urgent Field Safety Notice for EVOLUT PRO PLUS VALVE by Medtronic CoreValve, LLC PDF, 2MB, File does not meet accessibility standards Date: 31. March 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – cardiac surgery
Reference 32606/22

Urgent Field Safety Notice for Quadrox-i/-iD | VHK 11000 by Maquet Cardiopulmonary GmbH PDF, 2MB, File does not meet accessibility standards Date: 31. March 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 07866/23

Urgent Field Safety Notice for FlowSENS by Medex SAS PDF, 966KB, File does not meet accessibility standards Date: 29. March 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 05886/23

Urgent Field Safety Notice for Dihydrotestosteron-ELISA by EUROIMMUN Medizinische Labordiagnostika AG PDF, 699KB, File does not meet accessibility standards Date: 29. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 08929/23

Urgent Field Safety Notice for neon³ universal OCT spinal stabilization by Ulrich GmbH & Co. KG PDF, 204KB, File does not meet accessibility standards Date: 29. March 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 08950/23

Urgent Field Safety Notice for ANGIOGUARD RX/XP Emboli Capture Guidewire System by Cordis Corporation PDF, 262KB, File does not meet accessibility standards Date: 29. March 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 08987/23

Urgent Field Safety Notice for TIBIAL BASEPLATE STD RM/LL by Stryker Joint Replacement PDF, 222KB, File does not meet accessibility standards Date: 28. March 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 08736/23

Urgent Field Safety Notice for Seattle PAP plus, Neo Einweg-Atemschlauchsysteme, Koaxialbeatmungsschläuche,Pädiatrie Einweg-Atemschlauchsystem, Set2Go & Pack2Go by Drägerwerk AG & Co. KGaA PDF, 149KB, File does not meet accessibility standards Date: 28. March 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 08721/23

Urgent Field Safety Notice for BALLARD Oral Care Swabs by Avanos Medical Inc PDF, 186KB, File does not meet accessibility standards Date: 27. March 2023 Topics: Medical devices Type: Customer information

Product group Dental products – others
Reference 06033/23

Urgent Field Safety Notice for Shiley by Covidien llc PDF, 322KB, File does not meet accessibility standards Date: 27. March 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 08771/23

Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB PDF, 2MB, File does not meet accessibility standards Date: 27. March 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 04927/23

Urgent Field Safety Notice for Preloaded Injection System KS-X by STAAR Surgical AG PDF, 145KB, File does not meet accessibility standards Date: 27. March 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 08612/23

Urgent Field Safety Notice for EasyScreen Sample Processing Kit by Genetic Signatures Ltd PDF, 254KB, File does not meet accessibility standards Date: 27. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 08325/23

Urgent Field Safety Notice for Advance Micro 14 PTA-Ballonkatheter; Ultrathane Mehrzweck-Drainagekatheter mit Sperrschlaufe by Cook Incorporated PDF, 665KB, File does not meet accessibility standards Date: 24. March 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 08582/23

Urgent Field Safety Notice for QUICKSET by GRAFTYS, Pôle d’activités d’Aix en Provence, PDF, 190KB, File does not meet accessibility standards Date: 23. March 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – materials for implants
Reference 08461/23

Urgent Field Safety Notice for myoncare by ONCARE GmbH PDF, 199KB, File does not meet accessibility standards Date: 23. March 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 08210/23

Urgent Field Safety Notice for BARRIER TUR Set by Mölnlycke Health Care AB PDF, 1MB, File does not meet accessibility standards Date: 23. March 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 05443/23

Urgent Field Safety Notice for drill guide/ guide sleeve by aap Implantate AG PDF, 287KB, File does not meet accessibility standards Date: 23. March 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 07858/23

Urgent Field Safety Notice for Atellica DCA Analyzer and ACR Reagent Kit by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 186KB, File does not meet accessibility standards Date: 23. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 07834/23

Urgent Field Safety Notice for Qitexio – 20ml Luer Lock Syringe by Medex SAS PDF, 762KB, File does not meet accessibility standards Date: 23. March 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Reference 06576/23

Urgent Field Safety Notice for IMTEC-CIC IgG ELISA by HUMAN Gesellschaft für Biochemica und Diagnostica mbH PDF, 967KB, File does not meet accessibility standards Date: 23. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 06275/23

Urgent Field Safety Notice for LATERAL LUMBAR TI-LIFE PLATE by SPINEART S. (Plan-Les-Ouates) PDF, 661KB, File does not meet accessibility standards Date: 23. March 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 08464/23

Urgent Field Safety Notice for MicroVue C1-Inhibitor Plus EIA by Quidel Corporation Athens PDF, 592KB, File does not meet accessibility standards Date: 22. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 07521/23

Urgent Field Safety Notice for Stoffella DC Hallux Splint by Waldemar Link GmbH & Co. KG PDF, 2MB, File does not meet accessibility standards Date: 22. March 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 07704/23

Urgent Field Safety Notice for Flowstar by Medical Measurement Systems B.V. PDF, 353KB, File does not meet accessibility standards Date: 22. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 05787/23

Urgent Field Safety Notice for Micro-Dx by Molzym GmbH & Co. KG PDF, 2MB, File does not meet accessibility standards Date: 22. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 08181/23

Urgent Field Safety Notice for Contour next Blutzuckerteststreifen 25 S.ück by Ascensia Diabetes Care Holdings AG PDF, 1MB, File does not meet accessibility standards Date: 22. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 07168/23

Urgent Field Safety Notice for NO-Applikationsgerät by EKU ELEKTRONIK GMBH PDF, 66KB, File does not meet accessibility standards Date: 22. March 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 05696/23

Urgent Field Safety Notice for GM85 by Samsung Electronics Co. Limited PDF, 378KB, File does not meet accessibility standards Date: 21. March 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – mobile radiological diagnostic facilities
Reference 06687/23

Urgent Field Safety Notice for ACCY B31030 EXTENSION TUNNELER DBS by Medtronic Inc PDF, 2MB, File does not meet accessibility standards Date: 21. March 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – biostimulators
Reference 08007/23

Urgent Field Safety Notice for DigitalDiagnost by Philips Medical Systems DMC GmbH PDF, 1MB, File does not meet accessibility standards Date: 21. March 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 06134/23

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 389KB, File does not meet accessibility standards Date: 21. March 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – artificial hearts
Reference 32190/22

Urgent Field Safety Notice for Aquavent Neo Heated Ventilator Circuits, NeoFlow Humidified Oxygen Systems, Aquavent Neo nCPAP Systems by Armstrong Medical Ltd. PDF, 333KB, File does not meet accessibility standards Date: 21. March 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 06455/23

Urgent Field Safety Notice for Airo TruCT Mobile CT Scanner by Mobius Imaging, LLC PDF, 1MB, File does not meet accessibility standards Date: 21. March 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 34729/22

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 731KB, File does not meet accessibility standards Date: 17. March 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 34254/22

Urgent Field Safety Notice for ADVIA 2120/2120i Hematology System by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 223KB, File does not meet accessibility standards Date: 17. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 05023/23

Urgent Field Safety Notice for Verbindungsschläuche Trichter Fingertip by Extrudan S.. z o.o Zakrzewo PDF, 165KB, File does not meet accessibility standards Date: 17. March 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 05482/23

Urgent Field Safety Notice for Infinity CentralStation, Infinity M300/M300+ by Draeger Medical Systems, Inc PDF, 358KB, File does not meet accessibility standards Date: 17. March 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 07527/23

Urgent Field Safety Notice for Test Thrombin Reagent by Siemens Healthcare Diagnostics Products GmbH PDF, 181KB, File does not meet accessibility standards Date: 17. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 03801/23

Urgent Field Safety Notice for GENTA-COLL resorb, Collagen PARASORB RESODONT Forte, Collagen PARASORB RESODONT, Collagen GENTA-FOIL resorb and KOLLAGEN resorb by Resorba Medical GmbH PDF, 3MB, File does not meet accessibility standards Date: 17. March 2023 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – ointments and gels
Reference 07760/23

Urgent Field Safety Notice for Trunnion handle/woodpecker by Stemcup Medical Products AG PDF, 416KB, File does not meet accessibility standards Date: 16. March 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 06580/23

Urgent Field Safety Notice for AQURE system by Radiometer Medical ApS PDF, 93KB, File does not meet accessibility standards Date: 16. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 06130/23

Urgent Field Safety Notice for Power Knee by Össur hf. PDF, 226KB, File does not meet accessibility standards Date: 16. March 2023 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – prostheses (exoprostheses)
Reference 21032/22

Urgent Field Safety Notice for 17G Wallace Single#Lumen Oocyte Recovery Set by CooperSurgical, Inc. Trumbull PDF, 186KB, File does not meet accessibility standards Date: 16. March 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 02500/23

Urgent Field Safety Notice for CAPILLARYS IMMUNOTYPING by SEBIA PDF, 1MB, File does not meet accessibility standards Date: 16. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 07514/23

Urgent Field Safety Notice for Titan Inflatable Penile Prosthesis by Coloplast A/S PDF, 440KB, File does not meet accessibility standards Date: 15. March 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 06321/23

Urgent Field Safety Notice for Hamilton-C6 by Hamilton Medical AG PDF, 647KB, File does not meet accessibility standards Date: 15. March 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 05021/23

Urgent Field Safety Notice for Atrauma suction catheter, Stomach tube with mandrin, Duodenal tube, Suction cannula Yankauer, Suction cannula Standard, Suction catheter by P.J. Dahlhausen & Co. GmbH PDF, 950KB, File does not meet accessibility standards Date: 15. March 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 05935/23

Urgent Field Safety Notice for da Vinci Xi and da Vinci X Surgical System by Intuitive Surgical, Inc PDF, 4MB, File does not meet accessibility standards Date: 15. March 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 07009/23

Urgent Field Safety Notice for Functional Fibrinogen Kit by Haemonetics Corporation US PDF, 108KB, File does not meet accessibility standards Date: 14. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 04615/23

Urgent Field Safety Notice for Habib EndoHPB Bipolar Radiofrequency Catheter by Boston Scientific Corporation Marlborough PDF, 383KB, File does not meet accessibility standards Date: 14. March 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 06283/23

Urgent Field Safety Notice for 150CM EXT/INJ LINE STRAIGHT CT/MR by CAIR LGL PDF, 632KB, File does not meet accessibility standards Date: 14. March 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion kits
Reference 04933/23

Urgent Field Safety Notice for ACLELITE/ACL ELITEPRO/ACLElite Ref/ACLElitePro by Instrumentation Laboratory Co. PDF, 97KB, File does not meet accessibility standards Date: 14. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 05364/23

Urgent Field Safety Notice for Diathermy Suction Devices by Eakin Surgical Limited PDF, 215KB, File does not meet accessibility standards Date: 14. March 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 05803/23

Urgent Field Safety Notice for Component Neuromonitoring System by Moberg Research, Inc. PDF, 295KB, File does not meet accessibility standards Date: 13. March 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 05620/23

Urgent Field Safety Notice for Nexus KIS Medikationsmodul by NEXUS / DIS GmbH PDF, 427KB, File does not meet accessibility standards Date: 13. March 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 06132/23

Urgent Field Safety Notice for SmartPerfusion OWB; 2D Perfusion OWB by Philips Medical Systems Nederland B.V. PDF, 384KB, File does not meet accessibility standards Date: 10. March 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 05230/23

Urgent Field Safety Notice for Arterial Cannula by Edwards Lifesciences LLC PDF, 641KB, File does not meet accessibility standards Date: 09. March 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 06724/23

Urgent Field Safety Notice for AT TORBI 709MP by Carl Zeiss Meditec AG PDF, 2MB, File does not meet accessibility standards Date: 09. March 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 06563/23

Urgent Field Safety Notice for Trifecta Valve, Trifecta GT Valve by S.. Jude Medical, Costa Rica Ltd. (CS) PDF, 514KB, File does not meet accessibility standards Date: 08. March 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – cardiac surgery
Reference 05804/23

Urgent Field Safety Notice for LINK Schlittenprothese, Femurkomponenten, Tiviaplateaus by Waldemar Link GmbH & Co. KG PDF, 2MB, File does not meet accessibility standards Date: 08. March 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 05550/23

Urgent Field Safety Notice for ProteusPLUS by IBA (Ion Beam Applications) PDF, 2MB, File does not meet accessibility standards Date: 07. March 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – nuclear medical therapeutic equipment
Reference 09302/22

Urgent Field Safety Notice for S. Plus by Ganshorn Medizin Electronic GmbH PDF, 1MB, File does not meet accessibility standards Date: 07. March 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – pulmonary function diagnostics
Reference 04829/23

Urgent Field Safety Notice for BodyGuard Microset Infusion Set by Caesarea Medical Electronics Ltd. PDF, 2MB, File does not meet accessibility standards Date: 07. March 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 03681/23

Urgent Field Safety Notice for Leksell Stereotactic System by Elekta Solutions AB PDF, 341KB, File does not meet accessibility standards Date: 06. March 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 05777/23

Urgent Field Safety Notice for Vanguard Complete Knee System by Biomet Orthopedics, LLC PDF, 980KB, File does not meet accessibility standards Date: 03. March 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 05786/23

Urgent Field Safety Notice for injeTAK Adjustable Tip Needle by Laborie Medical Technologies Corp. PDF, 229KB, File does not meet accessibility standards Date: 03. March 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 04879/23

Urgent Field Safety Notice for ATTUNE Revision LPS Insert;DePuy ATTUNE Total Knee by DePuy Synthes Power Tools PDF, 234KB, File does not meet accessibility standards Date: 02. March 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 05313/23

Urgent Field Safety Notice for Single Use Rotatable Clip Fixing Device by Olympus Medical Systems Corp. PDF, 278KB, File does not meet accessibility standards Date: 01. March 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 03971/23

Urgent Field Safety Notice for Access 2 Immunoassay Analyzer (Refurbished), Access 2 Section, DxC 600i by Beckman Coulter, Inc. PDF, 751KB, File does not meet accessibility standards Date: 01. March 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 02997/23

Urgent Field Safety Notice for ENO/TEO/OTO/KORA 250 by MicroPort CRM S.r.l. PDF, 429KB, File does not meet accessibility standards Date: 01. March 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – cardiac pacemakers
Reference 05942/23

Urgent Field Safety Notice for Infusomat Space Line Type Transfusion by B. Braun Melsungen AG PDF, 1,023KB, File does not meet accessibility standards Date: 01. March 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 02204/23

Urgent Field Safety Notice for Cirq Arm System 2.0 by Brainlab AG PDF, 143KB, File does not meet accessibility standards Date: 01. March 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 05616/23

Urgent Field Safety Notice for CARDIOVIT CS-104 by Schiller AG PDF, 2MB, File does not meet accessibility standards Date: 01. March 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 05514/23

Urgent Field Safety Notice for Monaco RTP System by IMPAC Medical Systems, Inc. PDF, 211KB, File does not meet accessibility standards Date: 28. February 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 05483/23

Urgent Field Safety Notice for MCDh 1 by RAL DIAGNOSTICS PDF, 409KB, File does not meet accessibility standards Date: 27. February 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 03557/23

Urgent Field Safety Notice for Soft Denudation Tips + Follikel Punktions Systeme by Reproline medical GmbH PDF, 147KB, File does not meet accessibility standards Date: 27. February 2023 Topics: Medical devices Type: Customer information

Product group Contraception – others
Reference 04214/23

Urgent Field Safety Notice for FreeStyle LibreLink App, FreeStyle Libre 3 App by Abbott Diabetes Care Ltd. UK PDF, 126KB, File does not meet accessibility standards Date: 27. February 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – medical apps
Reference 03991/23

Urgent Field Safety Notice for Atellica DCA HbA1c Dx Reagent by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 279KB, File does not meet accessibility standards Date: 27. February 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 03670/23

Urgent Field Safety Notice for da Vinci X and da Vinci Surgical System by Intuitive Surgical, Inc. PDF, 2MB, File does not meet accessibility standards Date: 24. February 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 04645/23

Urgent Field Safety Notice for Chromogranin A RIA by DIAsource ImmunoAssays S.A. PDF, 330KB, File does not meet accessibility standards Date: 24. February 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 04110/23

Urgent Field Safety Notice for Atellica CH 930 Analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 153KB, File does not meet accessibility standards Date: 23. February 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 03483/23

Urgent Field Safety Notice for Mueller Hinton E Agar (MHE) by bioMérieux S. (Marcy- l’Etoile) PDF, 921KB, File does not meet accessibility standards Date: 23. February 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 02025/23

Urgent Field Safety Notice for Cardiosave Intraaortic Balloon Pump by Datascope Corp., Interventional Products Division PDF, 229KB, File does not meet accessibility standards Date: 23. February 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 34418/22

Urgent Field Safety Notice for Belzer UW Cold Storage Solution by Carnamedica S.. z o.o. PDF, 1MB, File does not meet accessibility standards Date: 22. February 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 03974/23

Urgent Field Safety Notice for mylife App by SINOVO health solutions GmbH PDF, 101KB, File does not meet accessibility standards Date: 22. February 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – medical apps
Reference 04141/23

Urgent Field Safety Notice for Bavarian Guide Wire RU by Medi-Globe GmbH PDF, 413KB, File does not meet accessibility standards Date: 21. February 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 04793/23

Urgent Field Safety Notice for Affinity Fusion Oxygenator mit integriertem arteriellen Filter und CVR by Medtronic Inc PDF, 209KB, File does not meet accessibility standards Date: 21. February 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 34245/22

Urgent Field Safety Notice for LIFEPAK CR2 defibrillator by Physio-Control, Inc. PDF, 227KB, File does not meet accessibility standards Date: 21. February 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 03286/23

Urgent Field Safety Notice for Denu Tips und Oocyte Aspiration Needles by Gynemed GmbH & Co. KG PDF, 198KB, File does not meet accessibility standards Date: 21. February 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 03943/23

Urgent Field Safety Notice for Guider Softip XF Guide Catheter by Boston Scientific Corporation Natick PDF, 736KB, File does not meet accessibility standards Date: 17. February 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 04358/23

Urgent Field Safety Notice for Dimension Tacrolimus (TACR) Flex reagent cartridge (-Calibrator DC107) by Siemens Healthcare Diagnostics Inc. Newark PDF, 163KB, File does not meet accessibility standards Date: 17. February 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 03161/23

Urgent Field Safety Notice for CardioMems Hospital and Patient Electronic System by S.. Jude Medical, Inc. – CardioMEMS PDF, 210KB, File does not meet accessibility standards Date: 16. February 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – measuring devices and sensors
Reference 03659/23

Urgent Field Safety Notice for Dornier Thulio Single Use Performance Laserfasern by Dornier MedTech America, Inc. PDF, 218KB, File does not meet accessibility standards Date: 15. February 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – laser technology
Reference 04196/23

Urgent Field Safety Notice for Monopolar Curved Shears by Covidien llc PDF, 112KB, File does not meet accessibility standards Date: 15. February 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 04466/23

Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB PDF, 1MB, File does not meet accessibility standards Date: 15. February 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 33137/22

Urgent Field Safety Notice for t:slim X2 Insulin Pump by Tandem Diabetes Care, Inc PDF, 124KB, File does not meet accessibility standards Date: 15. February 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 03805/23

Urgent Field Safety Notice for Efficia Pads Adapter Cable by Philips Goldway (Shenzhen) Industrial Inc. PDF, 3MB, File does not meet accessibility standards Date: 13. February 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 03664/23

Urgent Field Safety Notice for SureForm Stapler by Intuitive Surgical, Inc. PDF, 2MB, File does not meet accessibility standards Date: 13. February 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 03550/23

Urgent Field Safety Notice for Hugo RAS Arm Cart Assembly by Covidien llc PDF, 129KB, File does not meet accessibility standards Date: 10. February 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 03952/23

Urgent Field Safety Notice for V680 Ventilator by Respironics California, Inc. PDF, 378KB, File does not meet accessibility standards Date: 09. February 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 01230/23

Urgent Field Safety Notice for ExacTrac Dynamic by Brainlab AG PDF, 372KB, File does not meet accessibility standards Date: 09. February 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 03787/23

Urgent Field Safety Notice for Merit Procedure Packs (incl. Original Perfusor Line products) by Merit Medical Systems Inc. PDF, 1MB, File does not meet accessibility standards Date: 09. February 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 02942/23

Urgent Field Safety Notice for HF Sensor Delivery System by S.. Jude Medical, Inc. – CardioMEMS PDF, 1MB, File does not meet accessibility standards Date: 09. February 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – measuring devices and sensors
Reference 03660/23

Urgent Field Safety Notice for Efficia External Paddles by Philips Goldway (Shenzhen) Industrial Inc. PDF, 1MB, File does not meet accessibility standards Date: 09. February 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 03451/23

Urgent Field Safety Notice for RegenET by Regen Lab SA PDF, 3MB, File does not meet accessibility standards Date: 09. February 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – auxiliary equipment
Reference 03140/23

Urgent Field Safety Notice for Ceramill Zolid FX by Amann Girrbach AG PDF, 23KB, File does not meet accessibility standards Date: 08. February 2023 Topics: Medical devices Type: Customer information

Product group Dental products – dental prostheses
Reference 10055/21

Urgent Field Safety Notice for Babyroo TN300 by Draeger Medical Systems, Inc PDF, 234KB, File does not meet accessibility standards Date: 08. February 2023 Topics: Medical devices Type: Customer information

Product group Physical therapy – climatotherapy
Reference 34670/22

Urgent Field Safety Notice for Inquiry Steerable Diagnostic Catheter by S.. Jude Medical Irvine PDF, 515KB, File does not meet accessibility standards Date: 07. February 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 03137/23

Urgent Field Safety Notice for ARTIS pheno by Siemens Healthcare GmbH Advanced Therapies PDF, 1MB, File does not meet accessibility standards Date: 07. February 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 02822/23

Urgent Field Safety Notice for Ultra Clean Plus Surface Disinfection Lemon 5L by CB Healthcare Consulting GmbH PDF, 388KB, File does not meet accessibility standards Date: 07. February 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 02227/23

Urgent Field Safety Notice for HEMASHIELD PLATINUM Woven Double Velour by InterVascular S.A.S PDF, 205KB, File does not meet accessibility standards Date: 02. February 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 02086/23

Urgent Field Safety Notice for HLS Set Advanced 5.0, HLS Set Advanced 7.0, by Maquet Cardiopulmonary GmbH PDF, 3MB, File does not meet accessibility standards Date: 02. February 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 35354/22

Urgent Field Safety Notice for Scewo Bro V1 by Scewo AG PDF, 919KB, File does not meet accessibility standards Date: 01. February 2023 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – mobility aids
Reference 01104/23

Urgent Field Safety Notice for ARTIS pheno, ARTIS icono biplane/icono floor by Siemens Healthcare GmbH Advanced Therapies PDF, 381KB, File does not meet accessibility standards Date: 01. February 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 33949/22

Urgent Field Safety Notice for Tri-Staple 2.0 by Covidien llc PDF, 759KB, File does not meet accessibility standards Date: 31. January 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 02190/23

Urgent Field Safety Notice for COATED VICRYL PLUS SUTURE by Johnson & Johnson International PDF, 474KB, File does not meet accessibility standards Date: 31. January 2023 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – surgical sutures, vascular loops etc.
Reference 00156/23

Urgent Field Safety Notice for Cardiosave, CS100,CS300 Intra-Aortic Balloon Pumps by Datascope Corp., Patient Monitoring Division PDF, 507KB, File does not meet accessibility standards Date: 30. January 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 08166/19

Urgent Field Safety Notice for Furlong H-A.C Stem & H-A.C Revision Stem by JRI Orthopaedics Ltd. PDF, 699KB, File does not meet accessibility standards Date: 30. January 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 34447/22

Urgent Field Safety Notice for BEGO Semados S. 4.5 L8.5 by BEGO Implant Systems GmbH & Co. KG PDF, 238KB, File does not meet accessibility standards Date: 27. January 2023 Topics: Medical devices Type: Customer information

Product group Dental products – dental implants
Reference 01990/23

Urgent Field Safety Notice for Steeclo PWD 8626 und Steelco PWD 8628 by Miele & Cie. KG PDF, 213KB, File does not meet accessibility standards Date: 27. January 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 01082/23

Urgent Field Safety Notice for SEDECAL X URS by SEDECAL S. A. PDF, 852KB, File does not meet accessibility standards Date: 27. January 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 20326/22

Urgent Field Safety Notice for BOND Ready-to-Use Primary Antibody Bcl-6 (LN22) by Leica Biosystems Newcastle Ltd PDF, 1MB, File does not meet accessibility standards Date: 26. January 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 01567/23

Urgent Field Safety Notice for Flex ventilation hoses by Drägerwerk AG & Co. KGaA PDF, 447KB, File does not meet accessibility standards Date: 25. January 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 02047/23

Urgent Field Safety Notice for AT-102 / AT-102 plus / AT-10 plus /AT-104 PC / AT-104 PC ErgoSpiro by Schiller AG PDF, 315KB, File does not meet accessibility standards Date: 25. January 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 00458/23

Urgent Field Safety Notice for TRACOE experc Set twist, twist plus, vario by TRACOE medical GmbH Nieder-Olm PDF, 899KB, File does not meet accessibility standards Date: 25. January 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 01605/23

Urgent Field Safety Notice for Medtronic MiniMed Paradigm Infusion Pumps; Medtronic MiniMed Paradigm VEOTM; Medtronic MiniMed Infusion Pump by Medtronic Minimed PDF, 54KB, File does not meet accessibility standards Date: 25. January 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 01432/23

Urgent Field Safety Notice for gb PHARM UGT1A1 by GENERI BIOTECH s.r.o PDF, 3MB, File does not meet accessibility standards Date: 24. January 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 34613/22

Urgent Field Safety Notice for Ethanol Standard FS by DiaSys Diagnostic Systems GmbH PDF, 639KB, File does not meet accessibility standards Date: 24. January 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 34715/22

Urgent Field Safety Notice for Link Yankauer Sets and Suction Connecting Tubing by Ivor Shaw Ltd. (t/a Pennine Healthcare PDF, 178KB, File does not meet accessibility standards Date: 24. January 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 01860/23

Urgent Field Safety Notice for ORTHO Vision & Vision Max Analyzer by Ortho Clinical Diagnostics Inc. PDF, 424KB, File does not meet accessibility standards Date: 23. January 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 34741/22

Urgent Field Safety Notice for Infusomat Space Line Type Transfusion by B. Braun Melsungen AG PDF, 170KB, File does not meet accessibility standards Date: 20. January 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 00841/23

Urgent Field Safety Notice for Rüsch EndoGuide T by Teleflex (Perak West Malaysia) PDF, 591KB, File does not meet accessibility standards Date: 20. January 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 00982/23

Urgent Field Safety Notice for Cerebrospinal fluid shunt valve by Christoph Miethke GmbH & Co. KG PDF, 429KB, File does not meet accessibility standards Date: 20. January 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 00207/23

Urgent Field Safety Notice for Studio Reformer by Balanced Body, Inc. PDF, 326KB, File does not meet accessibility standards Date: 19. January 2023 Topics: Medical devices Type: Customer information

Product group Physical therapy – massage / mobility devices
Reference 35358/22

Urgent Field Safety Notice for Original Perfusor Line by B. Braun Melsungen AG PDF, 150KB, File does not meet accessibility standards Date: 18. January 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 01220/23

Urgent Field Safety Notice for Accu-Chek Solo cannula assembly & pump holder by Roche Diabetes Care GmbH PDF, 103KB, File does not meet accessibility standards Date: 18. January 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 32907/22

Urgent Field Safety Notice for Elecsys Troponin T hs / Elecsys Troponin T hs S.A. by Roche Diagnostics GmbH PDF, 748KB, File does not meet accessibility standards Date: 18. January 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 00012/23

Urgent Field Safety Notice for NovaStar plus, Nova Star TS by Drägerwerk AG & Co. KGaA PDF, 1MB, File does not meet accessibility standards Date: 17. January 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 00953/23

Urgent Field Safety Notice for WEB Detachment Controller (WDC) by MicroVention, Inc. PDF, 1MB, File does not meet accessibility standards Date: 16. January 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 01065/23

Urgent Field Safety Notice for Venovo Venous Stent System by Angiomed GmbH & Co. Medizintechnik KG PDF, 385KB, File does not meet accessibility standards Date: 16. January 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 00689/23

Urgent Field Safety Notice for PROSET MULTIPACK SYRINGES by B. Braun Melsungen AG PDF, 960KB, File does not meet accessibility standards Date: 13. January 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion kits
Reference 00840/23

Urgent Field Safety Notice for ProSet Intrafix SafeSet by B. Braun Melsungen AG PDF, 195KB, File does not meet accessibility standards Date: 13. January 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion kits
Reference 00856/23

Urgent Field Safety Notice for Medumat Standard 2 by WEINMANN Emergency Medical Technology GmbH + Co. KG PDF, 188KB, File does not meet accessibility standards Date: 13. January 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 00956/23

Urgent Field Safety Notice for Lina Librata – Endometrial Ablation Device by LiNA Medical ApS PDF, 1MB, File does not meet accessibility standards Date: 12. January 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 33779/22

Urgent Field Safety Notice for Fast-Cath Guiding Introducer Swartz S. Series by S.. Jude Medical, Inc.jetzt Abbott Plymouth PDF, 139KB, File does not meet accessibility standards Date: 12. January 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 00683/23

Urgent Field Safety Notice for Parietex Composite Mesh Polyester with Absorbable by Sofradim (subsidiary of Covidien) PDF, 2MB, File does not meet accessibility standards Date: 12. January 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 00823/23

Urgent Field Safety Notice for HemosIL AcuStar ADAMTS13-Activity Assay by Instrumentation Laboratory Co. PDF, 794KB, File does not meet accessibility standards Date: 12. January 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 04426/22

Urgent Field Safety Notice for Randox STFR & STFR Calibrator by Randox Laboratories Ltd PDF, 273KB, File does not meet accessibility standards Date: 12. January 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 13133/22

Urgent Field Safety Notice for ORISE Gel Submucosal Lifting Agent by Boston Scientific Corporation Marlborough PDF, 513KB, File does not meet accessibility standards Date: 12. January 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 27298/22

Urgent Field Safety Notice for 1stQ Hydrophilic Intraocular Lens by 1stQ GmbH PDF, 2MB, File does not meet accessibility standards Date: 11. January 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 30525/22

Urgent Field Safety Notice for Vivid i, Vivid q, Vivid S., Vivid S. by GE Medical Systems Israel, Functional Imaging PDF, 2MB, File does not meet accessibility standards Date: 11. January 2023 Topics: Medical devices Type: Customer information

Product group Ultrasonics – ultrasonic diagnostic equipment
Reference 00565/23

Urgent Field Safety Notice for Right coronal rod bender & Left coronal rod bender by SPINEVISION S.A. PDF, 384KB, File does not meet accessibility standards Date: 10. January 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 00033/23

Urgent Field Safety Notice for MUTARS® HD coupling C-O-M by implantcast GmbH PDF, 566KB, File does not meet accessibility standards Date: 10. January 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 33718/22

Urgent Field Safety Notice for Nuclear Medicine 600/800 series systems by GE Medical Systems Israel, Functional Imaging PDF, 4MB, File does not meet accessibility standards Date: 10. January 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – equipment for nuclear medical functional and localisation diagnostics
Reference 34730/22

Urgent Field Safety Notice for ThermoBrite Elite by Leica Biosystems Melbourne Pty Ltd PDF, 1MB, File does not meet accessibility standards Date: 10. January 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 33425/22

Urgent Field Safety Notice for Locking Cortical Screw, No.-Locking Hexalobe Screw by Acumed LLC. PDF, 1MB, File does not meet accessibility standards Date: 10. January 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 00457/23

Urgent Field Safety Notice for Defigard Touch 7 by Schiller Medical SAS PDF, 929KB, File does not meet accessibility standards Date: 10. January 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 34248/22

Urgent Field Safety Notice for Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30 und BiPAP A30/A40 Series by Philips Respironics, Inc. PDF, 1MB, File does not meet accessibility standards Date: 10. January 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 33127/22

Urgent Field Safety Notice for Triever 24 by Inari Medical PDF, 1MB, File does not meet accessibility standards Date: 09. January 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 34733/22

Urgent Field Safety Notice for Zenith Low Profile AAA Endovascular Graft Main Body by Cook Inc. PDF, 904KB, File does not meet accessibility standards Date: 09. January 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 33973/22

Urgent Field Safety Notice for Oxford Fixed Lateral by Biomet Orthopedics, LLC PDF, 643KB, File does not meet accessibility standards Date: 05. January 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 34681/22

Urgent Field Safety Notice for Invisalign System by Align Technology, Inc. San Jose PDF, 373KB, File does not meet accessibility standards Date: 05. January 2023 Topics: Medical devices Type: Customer information

Product group Dental products – orthodontic equipment
Reference 33387/22

Urgent Field Safety Notice for SOMATOM go.(diverse), x.cite/x.ceed, Naeotom Alpha by Siemens Healthcare GmbH Computed Tomography (CT) PDF, 893KB, File does not meet accessibility standards Date: 05. January 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 34739/22

Urgent Field Safety Notice for i.s.h.med by Cerner Corporation PDF, 104KB, File does not meet accessibility standards Date: 04. January 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 33398/22

Urgent Field Safety Notice for Vasoshield Pressure Controlling Syringe by Maquet Cardiovascular PDF, 796KB, File does not meet accessibility standards Date: 02. January 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – eye surgery
Reference 35113/22

Urgent Field Safety Notice for BIOSTOP G Bioresorbable Cement Restrictor by DePuy Ireland UC PDF, 647KB, File does not meet accessibility standards Date: 02. January 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 33424/22

Urgent Field Safety Notice for 3Dimensions and Selenia Dimensions by Hologic, Inc Marlborough PDF, 316KB, File does not meet accessibility standards Date: 02. January 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for mammographic diagnostics
Reference 34847/22