Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2021 – 31.03.2021

Опубліковано 02.04.2021 о 17:10

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  1. March 2021 Medical devicesCustomer information

Product group Active implantable medical devices – programming and control equipmentReference 05134/21

Urgent Field Safety Notice for Infusomat compact plus by B. Braun Melsungen AG, InfusionspumpenPDF, 41KB, File does not meet accessibility standards26. March 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technologyReference 05331/21

Urgent Field Safety Notice for Centricity Critical Care by GE HealthcarePDF, 942KB, File does not meet accessibility standards26. March 2021 Medical devicesCustomer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 05596/21

Urgent Field Safety Notice for UNI SCORE tibial tray for fixed bearing insert by Amplitude S.A.S.PDF, 670KB, File does not meet accessibility standards26. March 2021 Medical devicesCustomer information

Product group Non-active implants – bone surgeryReference 05243/21

Urgent Field Safety Notice for proSA Valve/ proSA Shuntsystem by Christoph Miethke GmbH & Co. KGPDF, 117KB, File does not meet accessibility standards26. March 2021 Medical devicesCustomer information

Product group Non-active implants – special implants
Reference 05563/21

Urgent Field Safety Notice for Surgiwand II Auto Suture Suction and Irrigation Device 5mm, Surgiwand II Auto Suture Suction and Irrigation Device with L-Hook Tip 5mm, Surgiwand II Auto Suture Suction and Irrigation Device with Spatula 5mm by Covidien llcPDF, 370KB, File does not meet accessibility standards25. March 2021 Medical devicesCustomer information

Product group Optics / Precision engineering – endoscopesReference 05490/21

Urgent Field Safety Notice for Artis Zee ceiling by Siemens Healthcare GmbH Advanced TherapiesPDF, 2MB, File does not meet accessibility standards25. March 2021 Medical devicesCustomer information

Product group Radiological technology – radiological equipment for vascular diagnosticsReference 05448/21

Urgent Field Safety Notice for Maxi Sky 1000 and V10 ceiling lifts by ArjoHuntleigh AB MalmöPDF, 519KB, File does not meet accessibility standards25. March 2021 Medical devicesCustomer information

Product group General equipment for medical treatment – ward equipment and equipment for emergency medical services
Reference 04099/21

Urgent Field Safety Notice for Disposable (Semi-)Automatic Biopsy Gun by Möller Medical GmbHPDF, 377KB, File does not meet accessibility standards25. March 2021 Medical devicesCustomer information

Product group Medical instruments for use in humans – general instrumentsReference 05198/21

Urgent Field Safety Notice for T-Cell Select by Oxford Immunotec Ltd.PDF, 65KB, File does not meet accessibility standards23. March 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – haematological, histological and cytological productsReference 04988/21

  1. March 2021 Medical devicesCustomer information

Product group Medical electronics / Electromedical devices – electrodiagnosticsReference 05596/21

Urgent Field Safety Notice for UNI SCORE tibial tray for fixed bearing insert by Amplitude S.A.S.PDF, 670KB, File does not meet accessibility standards26. March 2021 Medical devicesCustomer information

Product group Non-active implants – bone surgeryReference 05243/21

Urgent Field Safety Notice for proSA Valve/ proSA Shuntsystem by Christoph Miethke GmbH & Co. KGPDF, 117KB, File does not meet accessibility standards26. March 2021 Medical devicesCustomer information

Product group Non-active implants – special implantsReference 05563/21

Urgent Field Safety Notice for Surgiwand II Auto Suture Suction and Irrigation Device 5mm, Surgiwand II Auto Suture Suction and Irrigation Device with L-Hook Tip 5mm, Surgiwand II Auto Suture Suction and Irrigation Device with Spatula 5mm by Covidien llcPDF, 370KB, File does not meet accessibility standards25. March 2021 Medical devicesCustomer information

Product group Optics / Precision engineering – endoscopesReference 05490/21

Urgent Field Safety Notice for Artis Zee ceiling by Siemens Healthcare GmbH Advanced TherapiesPDF, 2MB, File does not meet accessibility standards25. March 2021 Medical devicesCustomer information

Product group Radiological technology – radiological equipment for vascular diagnosticsReference 05448/21

Urgent Field Safety Notice for Maxi Sky 1000 and V10 ceiling lifts by ArjoHuntleigh AB MalmöPDF, 519KB, File does not meet accessibility standards25. March 2021 Medical devicesCustomer information

Product group General equipment for medical treatment – ward equipment and equipment for emergency medical services
Reference 04099/21

Urgent Field Safety Notice for Disposable (Semi-)Automatic Biopsy Gun by Möller Medical GmbHPDF, 377KB, File does not meet accessibility standards25. March 2021 Medical devicesCustomer information

Product group Medical instruments for use in humans – general instrumentsReference 05198/21

Urgent Field Safety Notice for T-Cell Select by Oxford Immunotec Ltd.PDF, 65KB, File does not meet accessibility standards23. March 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – haematological, histological and cytological productsReference 04988/21

Urgent Field Safety Notice for Relay Plus and Relay 85 by Bolton Medical lnc.PDF, 204KB, File does not meet accessibility standards22. March 2021 Medical devicesCustomer information

Product group Non-active implants – special implantsReference 03738/21

Urgent Field Safety Notice for Arrow OnControl Bone Lesion Biopsy System Tray by Teleflex Medical AthlonePDF, 197KB, File does not meet accessibility standards19. March 2021 Medical devicesCustomer information

Product group Medical instruments for use in humans – general instrumentsReference 04719/21

Urgent Field Safety Notice for HeartStart FR2/FR2+ by Philips Healthcare, BothellPDF, 197KB, File does not meet accessibility standards19. March 2021 Medical devicesCustomer information

Product group Medical electronics / Electromedical devices – electrotherapyReference 04679/21

Urgent Field Safety Notice for ENROUTE Transcarotid Stent System by Silk Road Medical, Inc.PDF, 462KB, File does not meet accessibility standards19. March 2021 Medical devicesCustomer information

Product group Non-active implants – special implants
Reference 04463/21

Urgent Field Safety Notice for RetCam Envision Lens by Natus Medical Incorporated – OntarioPDF, 142KB, File does not meet accessibility standards19. March 2021 Medical devicesCustomer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics
Reference 04332/21

Urgent Field Safety Notice for Extreme H20 59 Xtra by Clerio VisionPDF, 131KB, File does not meet accessibility standards19. March 2021 Medical devicesCustomer information

Product group ophthalmological technology – contact lensesReference 05001/21

Urgent Field Safety Notice for Spiros by ICU Medical Inc.PDF, 210KB, File does not meet accessibility standards17. March 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technologyReference 04989/21

Urgent Field Safety Notice for MBT Cemented Keel Tibial Base 2 and ATTUNE FB AND RP by DePuy Ireland LtdPDF, 274KB, File does not meet accessibility standards15. March 2021 Medical devicesCustomer information

Product group Non-active implants – bone surgeryReference 04092/21

Urgent Field Safety Notice for WiSE CRT Transmitter by EBR Systems, INCPDF, 257KB, File does not meet accessibility standards12. March 2021 Medical devicesCustomer information

Product group Active implantable medical devices – cardiac pacemakersReference 04252/21

Urgent Field Safety Notice for Univation X Kneesystem by Aesculap AGPDF, 3MB, File does not meet accessibility standards12. March 2021 Medical devicesCustomer information

Product group Non-active implants – bone surgeryReference 04199/21

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Urgent Field Safety Notice for Relay Plus and Relay 85 by Bolton Medical lnc.PDF, 204KB, File does not meet accessibility standards

March 2021 Medical devicesCustomer information

Product group Non-active implants – special implantsReference 03738/21

Urgent Field Safety Notice for Arrow OnControl Bone Lesion Biopsy System Tray by Teleflex Medical AthlonePDF, 197KB, File does not meet accessibility standards19. March 2021 Medical devicesCustomer information

Product group Medical instruments for use in humans – general instrumentsReference 04719/21

Urgent Field Safety Notice for HeartStart FR2/FR2+ by Philips Healthcare, BothellPDF, 197KB, File does not meet accessibility standards19. March 2021 Medical devicesCustomer information

Product group Medical electronics / Electromedical devices – electrotherapyReference 04679/21

Urgent Field Safety Notice for ENROUTE Transcarotid Stent System by Silk Road Medical, Inc.PDF, 462KB, File does not meet accessibility standards19. March 2021 Medical devicesCustomer information

Product group Non-active implants – special implantsReference 04463/21

Urgent Field Safety Notice for RetCam Envision Lens by Natus Medical Incorporated – OntarioPDF, 142KB, File does not meet accessibility standards19. March 2021 Medical devicesCustomer information

Product group ophthalmological technology – equipment for ophthalmological diagnosticsReference 04332/21

Urgent Field Safety Notice for Extreme H20 59 Xtra by Clerio VisionPDF, 131KB, File does not meet accessibility standards19. March 2021 Medical devicesCustomer information

Product group ophthalmological technology – contact lensesReference 05001/21

Urgent Field Safety Notice for Spiros by ICU Medical Inc.PDF, 210KB, File does not meet accessibility standards17. March 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference
 04989/21

Urgent Field Safety Notice for MBT Cemented Keel Tibial Base 2 and ATTUNE FB AND RP by DePuy Ireland LtdPDF, 274KB, File does not meet accessibility standards15. March 2021 Medical devicesCustomer information

Product group Non-active implants – bone surgeryReference 04092/21

Urgent Field Safety Notice for WiSE CRT Transmitter by EBR Systems, INCPDF, 257KB, File does not meet accessibility standards12. March 2021 Medical devicesCustomer information

Product group Active implantable medical devices – cardiac pacemakersReference 04252/21

Urgent Field Safety Notice for Univation X Kneesystem by Aesculap AGPDF, 3MB, File does not meet accessibility standards12. March 2021 Medical devicesCustomer information

Product group Non-active implants – bone surgeryReference 04199/21

  1. March 2021 Medical devicesCustomer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supplyReference 04068/21

Urgent Field Safety Notice for Carag Bioresorbable Septal Occluder (CBSO) System by CARAG AGPDF, 70KB, File does not meet accessibility standards04. March 2021 Medical devicesCustomer information

Product group Non-active implants – cardiac surgeryReference 03547/21

Urgent Field Safety Notice for Hydraclair Ampullen by OTE Holding BVPDF, 147KB, File does not meet accessibility standards03. March 2021 Medical devicesCustomer information

Product group ophthalmological technology – liquid media for ophthalmological purposesReference 12069/20

Urgent Field Safety Notice for DiMix – ExactaMix – KabiHelp Uno – Nutri Bag by Diffuplast srlPDF, 107KB, File does not meet accessibility standards03. March 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technologyReference 03682/21

Urgent Field Safety Notice for Idova, Iforia, Ilesto/Inventra, Iperia, Itrevia/Ilivia, Inlexa, Intica/Ilivia Neo, Initca Neo by Biotronik S. & Co. KGPDF, 888KB, File does not meet accessibility standards03. March 2021 Medical devicesCustomer information

Product group Active implantable medical devices – defibrillatorsReference 04047/21

Urgent Field Safety Notice for YSIO X.pree by Siemens Healthcare GmbH, X-Ray Products (XP)PDF, 5MB, File does not meet accessibility standards03. March 2021 Medical devicesCustomer information

Product group Radiological technology – stationary radiological equipmentReference 03801/21

Urgent Field Safety Notice for Lifepak CR2 by Physio-Control, Inc.PDF, 1MB, File does not meet accessibility standards02. March 2021 Medical devicesCustomer information

Product group Medical electronics / Electromedical devices – electrotherapyReference 03151/21

Urgent Field Safety Notice for Incisive CT/MX 16 Slice/Access CT by Philips Healthcare (Suzhou) Co.,LtdPDF, 2MB, File does not meet accessibility standards02. March 2021 Medical devicesCustomer informationProduct group Radiological technology – CT scannersReference 03711/21

Urgent Field Safety Notice for SILK VISTA BABY by BALT ExtrusionPDF, 8MB, File does not meet accessibility standards02. March 2021 Medical devicesCustomer information

Product group Non-active implants – special implantsReference 03962/21

Urgent Field Safety Notice for ExacTrac Dynamic by Brainlab AGPDF, 220KB, File does not meet accessibility standards02. March 2021 Medical devicesCustomer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systemsReference 03645/21

  1. March 2021 Medical devicesCustomer information

Product group Non-active implants – bone surgeryReference 02988/21

Urgent Field Safety Notice for CryoMACS Freezing Bag 750 by Miltenyi Biotec GmbHPDF, 368KB, File does not meet accessibility standards26. February 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cellsReference 03096/21

Urgent Field Safety Notice for Anti-Xa by Roche Diagnostics GmbHPDF, 270KB, File does not meet accessibility standards26. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – haematological, histological and cytological productsReference 02948/21

Urgent Field Safety Notice for MATCH IT! DNA software by immucor GTI Diagnostics, Inc.PDF, 2MB, File does not meet accessibility standards26. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – instruments, apparatuses and systemsReference 03195/21

Urgent Field Safety Notice for Novocastra by Leica Biosystems Newcastle LtdPDF, 5MB, File does not meet accessibility standards26. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – immunological productsReference 03200/21

Urgent Field Safety Notice for VITROS SARS-CoV-2 Antigen Reagent by Ortho Clinical Diagnostics (Bridgend)PDF, 403KB, File does not meet accessibility standards26. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – microbiological productsReference 03225/21

Urgent Field Safety Notice for Artis icono and Artis pheno by Siemens Healthcare GmbH Advanced TherapiesPDF, 154KB, File does not meet accessibility standards26. February 2021 Medical devicesCustomer information

Product group Radiological technology – radiological equipment for vascular diagnosticsReference 03730/21

Urgent Field Safety Notice for Sterile Hypodermic Syringes for single Use by Hunan Pingan Medical Device Technology Co.,LtdPDF, 344KB, File does not meet accessibility standards25. February 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulasReference 03583/21

Urgent Field Safety Notice for CARTO Vizigo 8.5F Bi-Directional Guiding Sheath by Biosense Webster IncPDF, 310KB, File does not meet accessibility standards25. February 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – cathetersReference 03648/21

  1. February 2021 Medical devicesCustomer information

Product group Non-active implants – bone surgeryReference 22108/20

Urgent Field Safety Notice for DASH Omnipod Insulin Management System by Insulet Corporation LondonPDF, 397KB, File does not meet accessibility standards25. February 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technologyReference 01462/21

Urgent Field Safety Notice for Heater-Cooler Unit HCU 40 by Maquet Cardiopulmonary AGPDF, 106KB, File does not meet accessibility standards25. February 2021 Medical devicesCustomer information

Product group Surgical equipment/ Anaesthesia – surgical equipmentReference 02058/21

Urgent Field Safety Notice for NexSys by Haemonetics CorporationPDF, 269KB, File does not meet accessibility standards24. February 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – therapeutic apheresis proceduresReference 03432/21

Urgent Field Safety Notice for Becton Dickinson Syringes by Becton Dickinson France S.A.S.PDF, 687KB, File does not meet accessibility standards23. February 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulasReference 03423/21

Urgent Field Safety Notice for Blood Collection Systems and Filters by Haemonetics Corporation USPDF, 126KB, File does not meet accessibility standards23. February 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cellsReference 03419/21

Urgent Field Safety Notice for implacross PE insert 10° Ø 28/35mm by implantcast GmbHPDF, 529KB, File does not meet accessibility standards23. February 2021 Medical devicesCustomer information

Product group Non-active implants – bone surgeryReference 03221/21

Urgent Field Safety Notice for MetaVision Suite, Clinical Information System& EHR by iMDsoft Ltd.PDF, 376KB, File does not meet accessibility standards19. February 2021 Medical devicesCustomer information

Product group Medical data processing (software) – othersReference 02037/21

Urgent Field Safety Notice for PRECISE PRO Rx Carotid Stent System by Cordis CorporationPDF, 294KB, File does not meet accessibility standards19. February 2021 Medical devicesCustomer information

Product group Non-active implants – special implantsReference 03067/21

Urgent Field Safety Notice for Tru Flu by Meridian Bioscience, Inc.PDF, 3MB, File does not meet accessibility standards18. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – microbiological productsReference 03690/18

  1. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – microbiological productsReference 03891/18

Urgent Field Safety Notice for Atellica IM 1300 and IM 1600 Analyzers by Siemens Healthcare Diagnostics Inc. TarrytownPDF, 678KB, File does not meet accessibility standards18. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – equipment / products for clinical chemistryReference 06375/20

Urgent Field Safety Notice for Verigene Gram Positive Blood, Verigene Gram Negative Blood Culture, Verigene Gram Negative Blood Culture V2, Verigene RP Flex, and Vergiene Enteric Pathogens, Verigene CDF by Luminex Corporation USPDF, 155KB, File does not meet accessibility standards18. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – microbiological productsReference 17397/20

Urgent Field Safety Notice for Zinc by SENTINEL CH. SpAPDF, 298KB, File does not meet accessibility standards18. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – equipment / products for clinical chemistryReference 18391/20

Urgent Field Safety Notice for TPO Ab RIA by DIAsource ImmunoAssays S.A.PDF, 2MB, File does not meet accessibility standards18. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – immunological productsReference 19684/20

Urgent Field Safety Notice for ADVIA and Atellica GGT reagent by Siemens Healthcare Diagnostics Inc. NewarkPDF, 109KB, File does not meet accessibility standards18. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – equipment / products for clinical chemistryReference 20512/20

Urgent Field Safety Notice for Novocastra by Leica Biosystems Newcastle LtdPDF, 6MB, File does not meet accessibility standards18. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – immunological productsReference 21658/20

Urgent Field Safety Notice for CerTest S. pneumoniae + Legionella combo card test by CERTEST BIOTEC SLPDF, 172KB, File does not meet accessibility standards18. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – equipment / products for clinical chemistryReference 22037/20

Urgent Field Safety Notice for Dimension Vista High Density Lipoprotein Cholesterol Flex reagent cartridge by Siemens Healthcare Diagnostics Inc. NewarkPDF, 166KB, File does not meet accessibility standards18. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – equipment / products for clinical chemistryReference 01802/21

Urgent Field Safety Notice for KWIK-STIK 0947P-K-LYFO-DISK_QC Sets&Panels 5193P by Microbiologics, Inc.PDF, 396KB, File does not meet accessibility standards18. February 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – microbiological productsReference 02319/21

  1. February 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technologyReference 01707/21

Urgent Field Safety Notice for CAT Combat Application Tourniquet, schwarzGeneration 7C-A-TQT BLK BASE/GS ASSYENHANCD DESIGN TACTICAL BLACK C-A-TOURINIQUET WITH ELLIPTICAL END PROFILE by C.A.T Resources, LLCPDF, 98KB, File does not meet accessibility standards08. February 2021 Medical devicesCustomer information

Product group General equipment for medical treatment – medico-mechanical devicesReference 01017/21

Urgent Field Safety Notice for Universal Femoral Sleeve (S-ROM Noiles Rotating Hinge Knee System) by DePuy Orthopaedics, Inc.PDF, 58KB, File does not meet accessibility standards08. February 2021 Medical devicesCustomer information

Product group Non-active implants – bone surgeryReference 00598/21

Urgent Field Safety Notice for Mölnlycke Procedure Trays & Single Packed Shielded Bladed Trocars by Mölnlycke Health Care ABPDF, 308KB, File does not meet accessibility standards05. February 2021 Medical devicesCustomer information

Product group Medical instruments for use in humans – visceral surgeryReference 01273/21

Urgent Field Safety Notice for Strata II, Delta and Flow Control Valve by Medtronic IncPDF, 262KB, File does not meet accessibility standards05. February 2021 Medical devicesCustomer information

Product group Non-active implants – special implantsReference 00863/21

Urgent Field Safety Notice for Multiple Patienten Receiver by Nihon Kohden Corp.PDF, 930KB, File does not meet accessibility standards03. February 2021 Medical devicesCustomer information

Product group Medical electronics / Electromedical devices – electrodiagnosticsReference 00508A/21

Urgent Field Safety Notice for JETStream Workspace by Philips Healthcare (Cleveland)PDF, 719KB, File does not meet accessibility standards03. February 2021 Medical devicesCustomer information

Product group Radiological technology – CT scannersReference 22107/20

Urgent Field Safety Notice for SoKINOX/SERViNO by Maquet Critical Care ABPDF, 60KB, File does not meet accessibility standards03. February 2021 Medical devicesCustomer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supplyReference 01087/21

Urgent Field Safety Notice for Medumat Standard 2 by WEINMANN Emergency Medical Technology GmbH + Co. KGPDF, 70KB, File does not meet accessibility standards03. February 2021 Medical devicesCustomer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supplyReference 01156/21

Urgent Field Safety Notice for Parietex Hydrophilic Anatomical Mesh by Sofradim (subsidiary of Covidien)PDF, 241KB, File does not meet accessibility standards03. February 2021 Medical devicesCustomer information

Product group Non-active implants – special implantsReference 01392/21

  1. February 2021 Medical devicesCustomer information

Product group Non-active implants – bone surgeryReference 19613/20

Urgent Field Safety Notice for PrisMax Hemodialysis Machine by BaxterPDF, 154KB, File does not meet accessibility standards29. January 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – dialysis technologyReference 00939/21

Urgent Field Safety Notice for mint Lesion by Mint Medical GmbHPDF, 513KB, File does not meet accessibility standards28. January 2021 Medical devicesCustomer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicineReference 11251/20

Urgent Field Safety Notice for Sensis, Sensis Vibe Combo, Sensis Vibe Hemo by Siemens Healthcare GmbH, Advanced Therapies AngiographiePDF, 214KB, File does not meet accessibility standards27. January 2021 Medical devicesCustomer information

Product group Radiological technology – radiological equipment for vascular diagnostics Reference 01403/21

Urgent Field Safety Notice for GASTROINTESTINAL VIDEOSCOPE / COLONOVIDEOSCOPE by Olympus Medical Systems Corp.PDF, 150KB, File does not meet accessibility standards27. January 2021 Medical devicesCustomer information

Product group Optics / Precision engineering – endoscopesReference 00351/21

Urgent Field Safety Notice for BD syringes/Needles Pennine used in Custom Procedure Packs by Pennine HealthcarePDF, 113KB, File does not meet accessibility standards25. January 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulasReference 01138/21

  1. January 2021 Medical devicesCustomer information

Product group Optics / Precision engineering – endoscopesReference 01163/21

Urgent Field Safety Notice for 10MM FLEXTUBE NEO RESUS B/S WITH VARIABLE PEEP, DO by Intersurgical Ltd.PDF, 124KB, File does not meet accessibility standards22. January 2021 Medical devicesCustomer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supplyReference 01084/21

Urgent Field Safety Notice for Laerdal Compact Suction Unit (LCSU4) by Laerdal Medical ASPDF, 163KB, File does not meet accessibility standards22. January 2021 Medical devicesCustomer information

Product group Surgical equipment/ Anaesthesia – surgical equipmentReference 18124/20

Urgent Field Safety Notice for Minisart by Sartorius Stedim Biotech GmbHPDF, 79KB, File does not meet accessibility standards21. January 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – filtersReference 00639/21

Urgent Field Safety Notice for Natrium Citricum 4% by Biomedica, sopl s.r.oPDF, 922KB, File does not meet accessibility standards21. January 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – therapeutic apheresis proceduresReference 19299/20

Urgent Field Safety Notice for Hemodialyzers, ELISIOT-17H, ELISIOT-19H and ELISIOT-19M dialyzers by NIPRO INDIA CORPORATION PVT. LTD.PDF, 251KB, File does not meet accessibility standards21. January 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – dialysis technologyReference 20284/20

Urgent Field Safety Notice for ProxiDiagniost N90 by Philips Medical Systems DMC GmbHPDF, 2MB, File does not meet accessibility standards21. January 2021 Medical devicesCustomer information

Product group Radiological technology – stationary radiological equipmentReference 00906/21

Urgent Field Safety Notice for ENDOTHERAPY PRODUCTS DUE TO THE INTEGRITY OF STERILE PACKAGING by Olympus Medical Systems Corp.PDF, 282KB, File does not meet accessibility standards21. January 2021 Medical devicesCustomer information

Product group Non-active implants – bone surgeryReference 00612/21

Urgent Field Safety Notice for Atellica CH 930 Analyzer by Siemens Healthcare Diagnostics Inc. TarrytownPDF, 87KB, File does not meet accessibility standards19. January 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – equipment / products for clinical chemistryReference 01019/20

Urgent Field Safety Notice for cobas t511/t711 + Cuvette COBAS INTEGRA by Roche Diagnostics GmbHPDF, 573KB, File does not meet accessibility standards19. January 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – haematological, histological and cytological productsReference 09614/19

  1. January 2021 Medical devicesCustomer information

Product group Medical electronics / Electromedical devices – electrotherapyReference 00682/21

Urgent Field Safety Notice for Vivid iq, Vivid T8, Vivid T9 by GE Medical Systems (China) Co., Ltd.PDF, 250KB, File does not meet accessibility standards19. January 2021 Medical devicesCustomer information

Product group Ultrasonics – ultrasonic diagnostic equipmentReference 00719/21

Urgent Field Safety Notice for Natrium Citricum 4% by Biomedica, sopl s.r.oPDF, 933KB, File does not meet accessibility standards18. January 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – therapeutic apheresis proceduresReference 17860/20

Urgent Field Safety Notice for Access SARS-CoV-2 IgG Quality Control by Beckman CoulterPDF, 373KB, File does not meet accessibility standards18. January 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – microbiological productsReference 00268/21

Urgent Field Safety Notice for VivaDiag SARS-CoV-2 Ag Rapid Test by VivaChek Biotech (Hangzhou) Co., Ltd.PDF, 77KB, File does not meet accessibility standards18. January 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – microbiological productsReference 22487/20

Urgent Field Safety Notice for Multiple Patienten Receiver by Nihon Kohden Corp.PDF, 1MB, File does not meet accessibility standards18. January 2021 Medical devicesCustomer information

Product group Medical electronics / Electromedical devices – electrodiagnosticsReference 00508/21

Urgent Field Safety Notice for Infinity Acute Care System (IACS) by Draeger Medical Systems, IncPDF, 32KB, File does not meet accessibility standards18. January 2021 Medical devicesCustomer information

Product group Medical electronics / Electromedical devices – electrodiagnosticsReference 22822/20

Urgent Field Safety Notice for Getinge CM320-series by Getinge Disinfection ABPDF, 759KB, File does not meet accessibility standards14. January 2021 Medical devicesCustomer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisationReference 22291/20

Urgent Field Safety Notice for Vivostat Disposables – single use devices by Vivostat A/SPDF, 863KB, File does not meet accessibility standards14. January 2021 Medical devicesCustomer information

Product group Non-active implants – special implantsReference 19466/20

Urgent Field Safety Notice for Revolution Apex, Revolution CT by GE Medical Systems LLCPDF, 196KB, File does not meet accessibility standards14. January 2021 Medical devicesCustomer information

Product group Radiological technology – CT scannersReference 00388/21

  1. January 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – equipment / products for clinical chemistryReference 22351/20

Urgent Field Safety Notice for HEMOSPRAY ENDOSCOPIC HEMOSTAT by Cook EndoscopyPDF, 121KB, File does not meet accessibility standards08. January 2021 Medical devicesCustomer information

Product group Non-active implants – special implantsReference 00082/21

Urgent Field Safety Notice for Zystostom 10 Fr by Shaili EndoscopyPDF, 666KB, File does not meet accessibility standards08. January 2021 Medical devicesCustomer information

Product group Optics / Precision engineering – endoscopesReference 20750/20

Urgent Field Safety Notice for Portex Acapella DH (Green) Vibratory PEP Device by Smiths Medical ASD, Inc. (Plymouth)PDF, 144KB, File does not meet accessibility standards08. January 2021 Medical devicesCustomer information

Product group Physical therapy – insufflation techniqueReference 22180/20

Urgent Field Safety Notice for MODUS and MODUS 2 Pliers by Medartis AGPDF, 529KB, File does not meet accessibility standards07. January 2021 Medical devicesCustomer information

Product group Medical instruments for use in humans – bone surgeryReference 21977/20

Urgent Field Safety Notice for TLAB Transjugular Liver Biopsy System by Argon Medical Devices, Inc.PDF, 130KB, File does not meet accessibility standards06. January 2021 Medical devicesCustomer information

Product group Medical instruments for use in humans – general instrumentsReference 22160/20

Urgent Field Safety Notice for Hasson Trocar by Unimax Medical Systems Inc.PDF, 8MB, File does not meet accessibility standards06. January 2021 Medical devicesCustomer information

Product group Medical instruments for use in humans – visceral surgery Reference 22186/20

Urgent Field Safety Notice for Infusionsfilter 0,2µm by PMH-Produtos Médico Hospitalares, S.A.PDF, 3MB, File does not meet accessibility standards06. January 2021 Medical devicesCustomer information

Product group Injections / Infusions / Transfusions / Dialysis – filters Reference 17619/20

Urgent Field Safety Notice for APTT S. L Minus / APTT (SILICA) by Helena Biosciences EuropePDF, 2MB, File does not meet accessibility standards06. January 2021 Medical devicesCustomer information

Product group In-vitro diagnostics – haematological, histological and cytological products Reference 20067/20

Urgent Field Safety Notice for Intellis Clinician Programmer Application by Medtronic IncPDF, 366KB, File does not meet accessibility standards06. January 2021 Medical devicesCustomer information

Product group Active implantable medical devices – programming and control equipment Reference 22049/20

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