Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.04.2022 – 30.06.2023 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 Ultrasonic Soft Tissue Cutting and Sealing System by Suzhou Frankenman Medical Equipment Co., Ltd. PDF, 727KB, File does not meet accessibility standards Date: 16. June 2023 Topics: Medical devices Type: Customer information

Product group Ultrasonics – ultrasonic therapeutic equipment
Reference 16296/23

Urgent Field Safety Notice for domiflex, combiflex by Hermann Bock GmbH PDF, 735KB, File does not meet accessibility standards Date: 15. June 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – furnishings
Reference 15899/23

Urgent Field Safety Notice for Elekta Unity by Elekta Ltd PDF, 315KB, File does not meet accessibility standards Date: 15. June 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy
Reference 09895/23

Urgent Field Safety Notice for Megadyne, Megasoft, Mega 2000 Reusable Return Electrodes by Megadyne Medical Products Inc. PDF, 2MB, File does not meet accessibility standards Date: 14. June 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 15760/23

Urgent Field Safety Notice for directSTIM Patient Programmer Charger by Aleva Neurotherapeutics SA PDF, 132KB, File does not meet accessibility standards Date: 14. June 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – biostimulators
Reference 16565/23

Urgent Field Safety Notice for Allura Xper and Azurion systems by Philips Medical Systems Nederland B.V. PDF, 3MB, File does not meet accessibility standards Date: 14. June 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 16770/23

Urgent Field Safety Notice for EndoWrist Tip-Up Fenestrated Grasper by Intuitive Surgical, Inc PDF, 425KB, File does not meet accessibility standards Date: 14. June 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 17172/23

Urgent Field Safety Notice for ProSet Intrafix SafeSet by B. Braun Melsungen AG PDF, 227KB, File does not meet accessibility standards Date: 13. June 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion kits
Reference 15772/23

Urgent Field Safety Notice for ORBIS ICU-Manager by DH Healthcare GmbH PDF, 296KB, File does not meet accessibility standards Date: 13. June 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 15507/23

Urgent Field Safety Notice for Trackmaster Treadmills by Full Vision Inc PDF, 1MB, File does not meet accessibility standards Date: 12. June 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – functional diagnostics by way of gas exchange and exercise
Reference 15538/23

Urgent Field Safety Notice for DeepUnity Diagnost by DH Healthcare GmbH PDF, 698KB, File does not meet accessibility standards Date: 12. June 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 15801/23

Urgent Field Safety Notice for Damato Ruthenium Plaque Template by Altomed Limited PDF, 301KB, File does not meet accessibility standards Date: 09. June 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – nuclear medical therapeutic equipment
Reference 16229/23

Urgent Field Safety Notice for HAMILTON-C1, HAMILTON-T1, HAMILTON-C2, HAMILTON-C3 by Hamilton Medical AG PDF, 490KB, File does not meet accessibility standards Date: 09. June 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 15157/23

Urgent Field Safety Notice for Vanta Implantable Neurostimulator (INS) by Medtronic Inc PDF, 117KB, File does not meet accessibility standards Date: 09. June 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – biostimulators
Reference 16418/23

Urgent Field Safety Notice for Celex and Intelli-C EU by NRT-Nordisk Røntgen Teknik A/S PDF, 98KB, File does not meet accessibility standards Date: 09. June 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 14614/23

Urgent Field Safety Notice for MobileDiagnost wDR by Philips Medical Systems DMC GmbH PDF, 392KB, File does not meet accessibility standards Date: 07. June 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 14902/23

Urgent Field Safety Notice for UroPass Ureteral Access Sheath Set by Gyrus ACMI, Inc. PDF, 304KB, File does not meet accessibility standards Date: 07. June 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Reference 13117/23

Urgent Field Safety Notice for Nasal Splints by Exmoor Plastics Ltd. PDF, 1MB, File does not meet accessibility standards Date: 07. June 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 10209/23

Urgent Field Safety Notice for MH Guide by Molecular Health GmbH PDF, 527KB, File does not meet accessibility standards Date: 07. June 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 10277/23

Urgent Field Safety Notice for CEBOTARI Universal sternal retractor by FEHLING INSTRUMENTS GmbH & Co. KG PDF, 853KB, File does not meet accessibility standards Date: 07. June 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 09430/23

Urgent Field Safety Notice for LUISA by Löwenstein Medical Technology GmbH + Co. KG PDF, 462KB, File does not meet accessibility standards Date: 06. June 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 12043/23

Urgent Field Safety Notice for CAIMAN by Aesculap AG PDF, 3MB, File does not meet accessibility standards Date: 05. June 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 06538/23

Urgent Field Safety Notice for HemosIL Liquid Anti-Xa by Instrumentation Laboratory Co. PDF, 694KB, File does not meet accessibility standards Date: 02. June 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 11239/23

Urgent Field Safety Notice for FACILE Peripheral Vascular Self Expanding Stent System by Qualimed Innovative Medizinprodukte GmbH PDF, 213KB, File does not meet accessibility standards Date: 02. June 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 15594/23

Urgent Field Safety Notice for VasoView Hemopro 2 by Maquet Cardiovascular PDF, 530KB, File does not meet accessibility standards Date: 02. June 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 11254/23

Urgent Field Safety Notice for GLENOID COMPONENTS – OTHER by Lima Corporate S.p.A. PDF, 678KB, File does not meet accessibility standards Date: 02. June 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 06415/23

Urgent Field Safety Notice for RET Breakapart Probe by Cytocell Ltd PDF, 755KB, File does not meet accessibility standards Date: 02. June 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 14753/23

Urgent Field Safety Notice for HeartStart Intrepid by Philips Goldway (Shenzhen) Industrial Inc. PDF, 2MB, File does not meet accessibility standards Date: 02. June 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 15879/23

Urgent Field Safety Notice for Trilogy Evo, Trilogy Evo O2, Trilogy EV300 by Respironics, Inc. Pittsburgh PDF, 1MB, File does not meet accessibility standards Date: 02. June 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 10358/23

Urgent Field Safety Notice for Optergo Optical Ergonomic Solutions by Optergo AB PDF, 215KB, File does not meet accessibility standards Date: 02. June 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – others
Reference 13544/23

Urgent Field Safety Notice for Safe Locking System (SLS) for patient lifter by SCALEO MEDICAL PDF, 313KB, File does not meet accessibility standards Date: 02. June 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – ward equipment and equipment for emergency medical services
Reference 10907/23

Urgent Field Safety Notice for Oxylog 3000plus by Drägerwerk AG & Co. KGaA PDF, 723KB, File does not meet accessibility standards Date: 02. June 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 14632/23

Urgent Field Safety Notice for Surgical Blade, Brand- Baehr podoline by Paramount PDF, 724KB, File does not meet accessibility standards Date: 01. June 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 11950/23

Urgent Field Safety Notice for SurgiMend, PriMatrix by TEI Biosciences Inc PDF, 2MB, File does not meet accessibility standards Date: 01. June 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 15757/23

Urgent Field Safety Notice for EARLYVUE VS30 VITAL SIGNS MONITOR AND EARLYVUE VS3 by Philips Medizin Systeme Böblingen GmbH PDF, 421KB, File does not meet accessibility standards Date: 01. June 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 08189/23

Urgent Field Safety Notice for HEMOSPRAY ENDOSCOPIC HEMOSTAT by Cook Endoscopy PDF, 700KB, File does not meet accessibility standards Date: 01. June 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 14599/23

Urgent Field Safety Notice for NeoNavia CorePulse probe by NeoDynamics AB PDF, 1MB, File does not meet accessibility standards Date: 01. June 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 13255/23

Urgent Field Safety Notice for Gastrointestinal Flexible Endoscopes by Olympus Medical Systems Corp. PDF, 118KB, File does not meet accessibility standards Date: 01. June 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 12959/23

Urgent Field Safety Notice for Incisive CT by Philips Healthcare (Suzhou) Co.,Ltd PDF, 484KB, File does not meet accessibility standards Date: 31. May 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 12222/23

Urgent Field Safety Notice for TruCal PCT by DiaSys Diagnostic Systems GmbH PDF, 632KB, File does not meet accessibility standards Date: 31. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 15287/23

Urgent Field Safety Notice for Superset Fixed Elbow Catheter Mount 22F-22M/15F by Intersurgical Ltd. PDF, 509KB, File does not meet accessibility standards Date: 31. May 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 15477/23

Urgent Field Safety Notice for Endotracheal tubes by Teleflex (Perak West Malaysia) PDF, 25MB, File does not meet accessibility standards Date: 30. May 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 14886/23

Urgent Field Safety Notice for Sterile Ultrasound Gel by Turkuaz Saglik Hizmetleri Medikal Temizlik PDF, 454KB, File does not meet accessibility standards Date: 30. May 2023 Topics: Medical devices Type: Customer information

Product group Ultrasonics – ultrasonic diagnostic equipment
Reference 14332/23

Urgent Field Safety Notice for NOxBOXi by NOxBOX Ltd PDF, 443KB, File does not meet accessibility standards Date: 30. May 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 13937/23

Urgent Field Safety Notice for Cascadion S. Clinical Analyzer by Thermo Fisher Scientific Oy PDF, 357KB, File does not meet accessibility standards Date: 30. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 12963/23

Urgent Field Safety Notice for Access Hybritech p2PSA reagent by Beckman Coulter, Inc. PDF, 900KB, File does not meet accessibility standards Date: 30. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 14923/23

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 609KB, File does not meet accessibility standards Date: 25. May 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 08281/23

Urgent Field Safety Notice for Bicarbonate by Beckman Coulter Ireland Inc. PDF, 791KB, File does not meet accessibility standards Date: 25. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 10761/23

Urgent Field Safety Notice for Tunneling Instrument 600 mm by Aesculap AG PDF, 2MB, File does not meet accessibility standards Date: 25. May 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – neurosurgery
Reference 14584/23

Urgent Field Safety Notice for GenomEra molecular analyzer, GenomEra CDX System by Abacus Diagnostica Oy PDF, 539KB, File does not meet accessibility standards Date: 25. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 05442/23

Urgent Field Safety Notice for “.asy”-Dateien für recomWell Abarbeitung am DSX by Mikrogen GmbH PDF, 51KB, File does not meet accessibility standards Date: 24. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 10741/23

Urgent Field Safety Notice for Primedic HeartSave AED by Metrax GmbH PDF, 274KB, File does not meet accessibility standards Date: 24. May 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 14322/23

Urgent Field Safety Notice for A1AT-KONTROLLEN by SEBIA PDF, 599KB, File does not meet accessibility standards Date: 24. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 10202/23

Urgent Field Safety Notice for ADVIA Chemistry ToxAmmonia Calibrator, Atellica CH Toxicology Calibrator (TOX Cal) by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 292KB, File does not meet accessibility standards Date: 24. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 11295/23

Urgent Field Safety Notice for NanoZoomer by Hamamatsu Photonics K+. K+., Systems Division Joko Factory PDF, 1MB, File does not meet accessibility standards Date: 24. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 11126/23

Urgent Field Safety Notice for VITROS Chemistry Products HbA1c Reagent by Ortho-Clinical Diagnostics, Inc. PDF, 1MB, File does not meet accessibility standards Date: 23. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 11434/23

Urgent Field Safety Notice for HeartSine Samaritan PAD by Heartsine Technologies Limited PDF, 447KB, File does not meet accessibility standards Date: 23. May 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 14335/23

Urgent Field Safety Notice for iQ200 Series, DxU 850m and 840m Iris Analyzers by Beckman Coulter Inc. PDF, 594KB, File does not meet accessibility standards Date: 23. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 11414/23

Urgent Field Safety Notice for Immunoassay Premium Level 3, Immunoassay Premium by Randox Laboratories Ltd PDF, 2MB, File does not meet accessibility standards Date: 23. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 13572/23

Urgent Field Safety Notice for Incisive CT, CT3500 by Philips Healthcare (Suzhou) Co.,Ltd PDF, 2MB, File does not meet accessibility standards Date: 23. May 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 10875/23

Urgent Field Safety Notice for Smartdrive MX2+ mit Pushtracker E2/E3 by MaxMobility LLC, Lebanon PDF, 167KB, File does not meet accessibility standards Date: 22. May 2023 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – mobility aids
Reference 13248/23

Urgent Field Safety Notice for Sterile Ultrasound Gel by Turkuaz Saglik Hizmetleri Medikal Temizlik PDF, 546KB, File does not meet accessibility standards Date: 22. May 2023 Topics: Medical devices Type: Customer information

Product group Ultrasonics – ultrasonic diagnostic equipment
Reference 14229/23

Urgent Field Safety Notice for EliA GBM Well by Phadia AB PDF, 152KB, File does not meet accessibility standards Date: 19. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 13395/23

Urgent Field Safety Notice for Sonialvision Series (G4/Safire17/UD150B-40) by Shimadzu Corporation PDF, 98KB, File does not meet accessibility standards Date: 19. May 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 08027/23

Urgent Field Safety Notice for Anaconda by Vascutek Ltd PDF, 363KB, File does not meet accessibility standards Date: 16. May 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 33926/22

Urgent Field Safety Notice for Cobalt XT/Cobalt/Crome ICDs/CRT-Ds/Claria MRI/Amplia MRI/Compia MRI/Viva/Brava CRT-Ds/Visia AF/Visia AF MRI/Evera/Evera MRI/Primo MRI/Mirro MRI ICDs by Medtronic Inc. PDF, 301KB, File does not meet accessibility standards Date: 16. May 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – defibrillators
Reference 13556/23

Urgent Field Safety Notice for Softbed Resuscitaire with Scale by Draeger Medical Systems, Inc PDF, 112KB, File does not meet accessibility standards Date: 16. May 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – furnishings
Reference 13116/23

Urgent Field Safety Notice for Weck Horizon, HORIZON TI MICRO 6/CART 180/BOX by Teleflex Medical Morrisville PDF, 618KB, File does not meet accessibility standards Date: 16. May 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 12581/23

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 266KB, File does not meet accessibility standards Date: 15. May 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – artificial hearts
Reference 21994/20

Urgent Field Safety Notice for SECURODRAIN / NeuroVac Silikon-Flachdrainage by Neuromedex GmbH PDF, 1MB, File does not meet accessibility standards Date: 15. May 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 13911/23

Urgent Field Safety Notice for Nitril Examination Gloves by Smart Glove International Pte. Ltd. PDF, 372KB, File does not meet accessibility standards Date: 15. May 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – auxiliary equipment
Reference 13611/23

Urgent Field Safety Notice for Sonicaid Team3 by Huntleigh Healthcare Ltd. Diagnostics PDF, 8MB, File does not meet accessibility standards Date: 12. May 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 09761/23

Urgent Field Safety Notice for Dilatation balloon (DIL1-A1-Series) by FUJIFILM medwork GmbH PDF, 1MB, File does not meet accessibility standards Date: 12. May 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 07172/23

Urgent Field Safety Notice for VitreQ by Vitreq B.V. PDF, 135KB, File does not meet accessibility standards Date: 11. May 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – eye surgery
Reference 13396/23

Urgent Field Safety Notice for Medistrip by Neuromedex GmbH PDF, 1MB, File does not meet accessibility standards Date: 09. May 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – vascular surgery
Reference 12352/23

Urgent Field Safety Notice for PLASMACELL-C disposable set by Fresenius Kabi AG PDF, 134KB, File does not meet accessibility standards Date: 08. May 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells
Reference 11680/23

Urgent Field Safety Notice for BARRIER TUR Set by Mölnlycke Health Care AB PDF, 1MB, File does not meet accessibility standards Date: 05. May 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 12047/23

Urgent Field Safety Notice for 3Dose Syringe by BIMED TEKNIK ALETLER SANAYI VE TICARET A.S. PDF, 116KB, File does not meet accessibility standards Date: 05. May 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Reference 10893/23

Urgent Field Safety Notice for EliA GliadinDP IgG Well by Phadia AB PDF, 177KB, File does not meet accessibility standards Date: 05. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 12052/23

Urgent Field Safety Notice for SINGLE USE REPOSITIONABLE CLIP HX-202LR/UR by Olympus Medical Systems Corp. PDF, 276KB, File does not meet accessibility standards Date: 05. May 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 11691/23

Urgent Field Safety Notice for Linear Accelerator (Varex PSU) by Elekta Ltd PDF, 166KB, File does not meet accessibility standards Date: 04. May 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy
Reference 12798/23

Urgent Field Safety Notice for VENTRALIGHT S. Mesh with ECHO PS Positioning System by Davol Inc. PDF, 427KB, File does not meet accessibility standards Date: 04. May 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 12502/23

Urgent Field Safety Notice for NextSeq 550Dx Instrument / MiSeq Dx Instrument by Illumina, Inc. PDF, 1MB, File does not meet accessibility standards Date: 04. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 12357/23

Urgent Field Safety Notice for Alinity i Anti-TPO Reagent Kit by Abbott Ireland Diagnostics Division PDF, 173KB, File does not meet accessibility standards Date: 04. May 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 12197/23

Urgent Field Safety Notice for NE’X Glue Surgical Adhesive by Grena Biomed Limited PDF, 1MB, File does not meet accessibility standards Date: 04. May 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 35359/22

Urgent Field Safety Notice for Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series, AC3T Series IABP System by Teleflex Medical USA PDF, 639KB, File does not meet accessibility standards Date: 03. May 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 11918/23

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 497KB, File does not meet accessibility standards Date: 02. May 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 07192/23

Urgent Field Safety Notice for TAKE-APART Bipolar Spring or Ring Handle by Karl Storz S. & Co KG PDF, 525KB, File does not meet accessibility standards Date: 02. May 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 11958/23

Urgent Field Safety Notice for Behandlungsstuhl 500 XLE by UFSK-International OSYS GmbH PDF, 1MB, File does not meet accessibility standards Date: 02. May 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – furnishings
Reference 11684/23

Urgent Field Safety Notice for exoplan by exocad GmbH PDF, 1MB, File does not meet accessibility standards Date: 29. April 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – software for computer-based treatment
Reference 11938/23

Urgent Field Safety Notice for Icelock ratchet by Össur hf. PDF, 377KB, File does not meet accessibility standards Date: 28. April 2023 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – prostheses (exoprostheses)
Reference 11571/23

Urgent Field Safety Notice for Revolution ACTs, ACTs by WIPRO GE Healthcare Private Ltd. PDF, 281KB, File does not meet accessibility standards Date: 28. April 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 11921/23

Urgent Field Safety Notice for 4K CAMERA HEAD CH-S400-XZ-EB by Olympus Medical Systems Corp. PDF, 288KB, File does not meet accessibility standards Date: 27. April 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 10201/23

Urgent Field Safety Notice for Sterilisation Container by Spiggle & Theis Medizintechnik GmbH PDF, 1MB, File does not meet accessibility standards Date: 27. April 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 11915/23

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 519KB, File does not meet accessibility standards Date: 27. April 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 06833/23

Urgent Field Safety Notice for Bioknotless Anchor (Arthroscopic) by DePuy Mitek PDF, 741KB, File does not meet accessibility standards Date: 27. April 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 11806/23

Urgent Field Safety Notice for Cemvac Revision Nozzle 6.5mm & 8.5mm by DePuy Ireland UC PDF, 1MB, File does not meet accessibility standards Date: 27. April 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 11467/23

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 698KB, File does not meet accessibility standards Date: 27. April 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 07680/23

Urgent Field Safety Notice for HELIOSTAR Balloon Ablation Catheter by Biosense Webster Inc PDF, 1MB, File does not meet accessibility standards Date: 27. April 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 04791/23

Urgent Field Safety Notice for CombiDiagnost R90/ProxiDiagnost N90 by Philips Medical Systems DMC GmbH PDF, 3MB, File does not meet accessibility standards Date: 26. April 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 06882/23

Urgent Field Safety Notice for Synergy Cranial, StealthStation Cranial by Medtronic Navigation Inc. PDF, 2MB, File does not meet accessibility standards Date: 25. April 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – navigation systems
Reference 11920/23

Urgent Field Safety Notice for Distale Einwegabdeckung by Olympus Deutschland GmbH PDF, 795KB, File does not meet accessibility standards Date: 25. April 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 10604/23

Urgent Field Safety Notice for LinkSymphoKnee System, Femuraugment L-Form by Waldemar Link GmbH & Co. KG PDF, 1MB, File does not meet accessibility standards Date: 25. April 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 11801/23

Urgent Field Safety Notice for VenoTrain business by Bauerfeind AG PDF, 606KB, File does not meet accessibility standards Date: 25. April 2023 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – orthoses
Reference 10823/23

Urgent Field Safety Notice for Impella 5.5 mit SmartAssist Herzpumpe by Abiomed Europe GmbH PDF, 213KB, File does not meet accessibility standards Date: 25. April 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 11195/23

Urgent Field Safety Notice for DHT ELISA by LDN Labordiagnostika Nord GmbH & Co.KG PDF, 538KB, File does not meet accessibility standards Date: 24. April 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 10885/23

Urgent Field Safety Notice for UBC Rapid by IDL Biotech PDF, 248KB, File does not meet accessibility standards Date: 24. April 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 11572/23

Urgent Field Safety Notice for NEUROTUBE, 02X40,RP, CE by Synovis Micro Companies Alliance, Inc. PDF, 569KB, File does not meet accessibility standards Date: 24. April 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – other implants
Reference 10146/23

Urgent Field Safety Notice for Defigard Touch 7 by Schiller Medical SAS PDF, 114KB, File does not meet accessibility standards Date: 20. April 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 10983/23

Urgent Field Safety Notice for Software VeriSoft, Software BeamAdjust by PTW Freiburg, Physikalisch-Technische Werkstätten Dr. Pychlau GmbH PDF, 116KB, File does not meet accessibility standards Date: 20. April 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 10290/23

Urgent Field Safety Notice for AquaPak 340 ml by Teleflex Medical Morrisville PDF, 514KB, File does not meet accessibility standards Date: 20. April 2023 Topics: Medical devices Type: Customer information

Product group Physical therapy – insufflation technique
Reference 02957/23

Urgent Field Safety Notice for Pneumostat by Atrium Medical Corporation Merrimack PDF, 234KB, File does not meet accessibility standards Date: 20. April 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 10739/23

Urgent Field Safety Notice for Procedure Packs (Kitpacks) containing Redon Bottle by Lohmann und Rauscher GmbH & Co. KG PDF, 87KB, File does not meet accessibility standards Date: 20. April 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 10909/23

Urgent Field Safety Notice for Osteobioptom by FEHLING INSTRUMENTS GmbH & Co. KG PDF, 70KB, File does not meet accessibility standards Date: 18. April 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 11021/23

Urgent Field Safety Notice for DURAClone B27 Reagent Kit by Beckman Coulter India Pvt Limited PDF, 994KB, File does not meet accessibility standards Date: 17. April 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 10051/23

Urgent Field Safety Notice for Philips Hemodynamic system. by Philips Medical Systems Nederland B.V. PDF, 2MB, File does not meet accessibility standards Date: 17. April 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 08613/23

Urgent Field Safety Notice for SINGLE USE ASPIRATION NEEDLE by Gyrus ACMI – Olympus – OSTA PDF, 206KB, File does not meet accessibility standards Date: 17. April 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 10066/23

Urgent Field Safety Notice for Inzisions-Instrument,70 mm by SCILO Vertriebs GmbH PDF, 468KB, File does not meet accessibility standards Date: 14. April 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 08495/23

Urgent Field Safety Notice for Trilogy Evo O2, Trilogy EV300 by Respironics, Inc. Pittsburgh PDF, 672KB, File does not meet accessibility standards Date: 14. April 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 07025/23

Urgent Field Safety Notice for Express Mini 500 Dr. Seal Chest Drain by Atrium Medical Corporation Merrimack PDF, 685KB, File does not meet accessibility standards Date: 14. April 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 10038/23

Urgent Field Safety Notice for Global Total LP single step medium, 60mL by CooperSurgical, Inc. Trumbull PDF, 129KB, File does not meet accessibility standards Date: 14. April 2023 Topics: Medical devices Type: Customer information

Product group Physical therapy – others
Reference 04574/23

Urgent Field Safety Notice for Dale Medical Catheter Securement Device by Dale Medical Products, Inc. PDF, 2MB, File does not meet accessibility standards Date: 14. April 2023 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – bandages
Reference 09932/23

Urgent Field Safety Notice for PRECICE BONE TRANSPORT System by NuVasive Specialized Orthopedics, Inc., a division of NuVasive, Inc. PDF, 510KB, File does not meet accessibility standards Date: 14. April 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – others
Reference 09359/23

Urgent Field Safety Notice for S-Cryolock by Biotech, Inc. PDF, 2MB, File does not meet accessibility standards Date: 13. April 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – dosing systems
Reference 10161/23

Urgent Field Safety Notice for Jelco Conventional Optiva IV Catheters by Smiths Medical ASD, lnc. PDF, 1MB, File does not meet accessibility standards Date: 12. April 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 10563/23

Urgent Field Safety Notice for Spectral CT 7500 by Philips Medical Systems Nederland B.V. PDF, 1MB, File does not meet accessibility standards Date: 12. April 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 08329/23

Urgent Field Safety Notice for MANI Trocar Kit by MANI, INC. PDF, 530KB, File does not meet accessibility standards Date: 12. April 2023 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological therapeutics
Reference 06720/23

Urgent Field Safety Notice for Ingenia Elition, MR 7700 by Philips Medical Systems Nederland B.V. PDF, 2MB, File does not meet accessibility standards Date: 12. April 2023 Topics: Medical devices Type: Customer information

Product group Electromedical fields – equipment for MR tomography
Reference 31507/22

Urgent Field Safety Notice for Hugo RAS Arm Cart Assembly by Covidien llc PDF, 124KB, File does not meet accessibility standards Date: 12. April 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 06456/22

Urgent Field Safety Notice for WATCHDOG Hemostasis Valve Kit by Boston Scientific Corporation Marlborough PDF, 220KB, File does not meet accessibility standards Date: 11. April 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion kits
Reference 10074/23

Urgent Field Safety Notice for Azurion by Philips Medical Systems Nederland B.V. PDF, 403KB, File does not meet accessibility standards Date: 11. April 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 08195/23

Urgent Field Safety Notice for AquaPak 340 ml by Teleflex Medical Morrisville PDF, 859KB, File does not meet accessibility standards Date: 11. April 2023 Topics: Medical devices Type: Customer information

Product group Physical therapy – insufflation technique
Reference 10045/23

Urgent Field Safety Notice for COOK-Medical-TracheomieKit-Einmalprodukt-Blue Rhino G2-Multi Percutaneous by Cook Inc. PDF, 1MB, File does not meet accessibility standards Date: 11. April 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 10044/23

Urgent Field Safety Notice for Codman Cranial Hand Drill by Integra LifeSciences Mansfield PDF, 286KB, File does not meet accessibility standards Date: 11. April 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 09921/23

Urgent Field Safety Notice for Tempus LS by Schiller AG PDF, 6MB, File does not meet accessibility standards Date: 06. April 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 08802/23

Urgent Field Safety Notice for Incisive CT by Philips Healthcare (Suzhou) Co.,Ltd PDF, 2MB, File does not meet accessibility standards Date: 06. April 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 08471/23

Urgent Field Safety Notice for Drainage Set LiquoGuard 7 by Möller Medical GmbH PDF, 1MB, File does not meet accessibility standards Date: 06. April 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 08785/23

Urgent Field Safety Notice for FLEX. GREIFZANGE bzw. FLEX. PE-ZANGE by Richard Wolf GmbH PDF, 694KB, File does not meet accessibility standards Date: 06. April 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 07243/23

Urgent Field Safety Notice for Aptio Automation by Inpeco SA PDF, 967KB, File does not meet accessibility standards Date: 06. April 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 07278/23

Urgent Field Safety Notice for Sinus by HS Doms GmbH PDF, 173KB, File does not meet accessibility standards Date: 05. April 2023 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics
Reference 09411/23

Urgent Field Safety Notice for Ecocentric by HS Doms GmbH PDF, 173KB, File does not meet accessibility standards Date: 05. April 2023 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics
Reference 09410/23

Urgent Field Safety Notice for HS-810 by HS Doms GmbH PDF, 173KB, File does not meet accessibility standards Date: 05. April 2023 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics
Reference 08959/23

Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB PDF, 2MB, File does not meet accessibility standards Date: 05. April 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 03669/23

Urgent Field Safety Notice for 1057 MRiduim MRI Infusion Syringe Adapter Set by IRadimed Corporation PDF, 164KB, File does not meet accessibility standards Date: 05. April 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 08341/23

Urgent Field Safety Notice for CryoTreQ by Vitreq B.V. PDF, 1MB, File does not meet accessibility standards Date: 04. April 2023 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological therapeutics
Reference 07987/23

Urgent Field Safety Notice for Fujifilm Synapse PACS by FUJIFILM Medical System U.S.A., Inc. PDF, 183KB, File does not meet accessibility standards Date: 04. April 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 09157/23

Urgent Field Safety Notice for ANA Profile 8 ELISA by IBL International GmbH PDF, 106KB, File does not meet accessibility standards Date: 04. April 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 09551/23

Urgent Field Safety Notice for Medizym anti-IA2 M by MEDIPAN GMBH PDF, 54KB, File does not meet accessibility standards Date: 04. April 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 09546/23

Urgent Field Safety Notice for K+ölner Drainage; Redon Bottle by pfm medical mepro gmbh PDF, 1MB, File does not meet accessibility standards Date: 03. April 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 09454/23

Urgent Field Safety Notice for Atellica IM Cortisol, ADVIA Centaur Cortisol by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 203KB, File does not meet accessibility standards Date: 03. April 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 09097/23

Urgent Field Safety Notice for Accelerator a3600 by Inpeco SA PDF, 188KB, File does not meet accessibility standards Date: 03. April 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 07277/23

Urgent Field Safety Notice for ASEPT System zur Pleuraldrainage; Peritonealdrain. by PFM Medical, Inc. PDF, 1MB, File does not meet accessibility standards Date: 03. April 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 08770/23

Urgent Field Safety Notice for Orbitalretraktor rechts (M2-2122), links (M2-2121) by Medartis AG PDF, 1MB, File does not meet accessibility standards Date: 03. April 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 09261/23

Urgent Field Safety Notice for IntellaNav S. Ablation Catheter by Boston Scientific Corporation Marlborough PDF, 2MB, File does not meet accessibility standards Date: 03. April 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 08795/23