Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Endologix Inc, FSN-FS-0012, Ovation Abdominal Stent Graft System Platform

   This FSN is specific to the following Ovation iX Abdominal Stent Graft Systems, and impacts all lot/serial numbers: TV-AB2080-I, ...

   Waarschuwing | 06-05-2020

2. GE Medical Systems Information Technologies, Inc.,FMI 36145 Carescape One

   The CARESCAPE ONE monitor may lose ECG parameter and waveform data when used in conjunction with an Automated External ...

   Waarschuwing | 30-04-2020

3. Medtronic Inc, FSN-FA914, TriageHF Data Calculation Module (DCM)

   Disabling of TriageHF™ CareAlerts CareLink™ Network

   Waarschuwing | 29-04-2020

4. Philips Medical Systems FSCA 86100197A-IR Internal Sterilizable Defibrillator paddles

   Interne paddles kunnen na verloop van tijd slijten en zijn mogelijk niet veilig of gereed voor gebruik, tenzij de aanwijzingen in ...

   Waarschuwing | 24-04-2020

5. Bentley InnoMed GmbH CAPA 20-003 Mesh-sleeve coronary artery stent

   During the last internal quality control (destructive testing during final release test), it was found that there is a potential ...

   Waarschuwing | 22-04-2020

6. Becton Dickinson MDS-20-1971 - BD PosiFlush™ XS 10mL Syringe

   BD has become aware through customer feedback that a percentage of BD PosiFlush™ XS 10mL Syringes (REF: 306572) have the ...

   Waarschuwing | 21-04-2020

7. Defibtech FA2020-01 - DDU-2000 Series Automated External Defibrillator (AED)

   This corrective action addresses a hardware issue with a particular electrical component used in the identified AEDs.  This ...

   Waarschuwing | 21-04-2020

8. Medtronic, Inc. FA908 HeartWare® Ventricular Assist System (HVAD)

   Van de bijna 22.000 HVAD-pompen die tot en met 5 maart 2020 zijn gedistribueerd, heeft Medtronic 92 klachten (0,42%) ontvangen ...

   Waarschuwing | 07-04-2020

9. The Spectranetics Corporation D055703 Bridge® Occlusion Balloon

   The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in ...

   Waarschuwing | 26-03-2020

10. Teleflex_Vascular Solutions HRA00077 - Langston Dual Lumen Catheter

    Op de datum van deze brief heeft Vascular Solutions LLC, een dochteronderneming van Teleflex, acht meldingen ontvangen waarbij ...

    Waarschuwing | 25-03-2020