Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. A&E Medical Corporation 2017-10-20 - SURGICAL PUNCH

   All A&E Medical Surgical Punches are being recalled due to potential packaging damage which may have occurred during ...

   Waarschuwing | 20-10-2017

2. Leica Microsystems, Proveo 8 Ophthalmic Microscope System

   As to Proveo 8, one of Leica Microsystems' Ophthalmic Surgical Microscope, a series of intermittent issues which negatively ...

   Waarschuwing | 12-09-2017

3. Field Safety Notice: Implant Direct Sybron Manufacturing LLC, Spectra-System®

   Through our Regulatory Affairs reporting process we have found that the product may be out of Implant Direct specification.

   Waarschuwing | 27-07-2017

4. Field Safety Notice: COOK Medical - Stamey Needle, Clarke-Reich Laparoscopic Knot Pusher, Endoscopic Introducer/Extractor, Pereyra Ligature Carrier ‘75®, Pereyra-Raz Ligature Carrier™

   We have identified the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, ...

   Waarschuwing | 24-04-2017

5. Field Safety Notice: ELLA-CS - Danis Procedure Pack (Basic)

   Based on analysis of a returned product, company ELLA-CS, s.r.o. has identified that an unintended movement of the safety valve ...

   Waarschuwing | 14-02-2017

6. Zimmer Dental RN15-003 NL - Trabecular Metal Dental Implant

   Through investigation, Zimmer Dental determined that information specific to the 3.7mmD and 4.1mmD Trabecular Metal implants was ...

   Waarschuwing | 08-01-2016

7. Biosense Webster, THERMOCOOL®

   De fabrikant heeft recent een toenemend aantal klachten met betrekking tot de display van fout/alarm melding “Alert 402” van het ...

   Waarschuwing | 12-09-2017

8. AMO Manufacturing USA, LLC, FSN-FSCA -01-2021 - 2031730, Catalys® and iDesign®

   JJSV geeft deze Field Safety Notice uit vanwege een kwetsbaarheid op het gebied van cyberbeveiliging voor iDESIGN® Refractive ...

   Waarschuwing | 18-01-2022

9. Integra LifeSciences (Ireland) Ltd, CUSA Clarity voetschakelaar

   De verkeerde voetschakelaar kan tot onbedoelde ultrasone fragmentatie activering leiden.

   Waarschuwing | 25-09-2017

10. RanD S.p.A., FSN-FSCA-SM02-21, Disposable devices and accessories for Hyperthermic Perfusion treatments for use with PERFOMER HT and PERFORMER LRT equipment

    Deze veiligheidswaarschuwing maakt onderdeel uit van een groter Europees onderzoek naar vervalste certificaten. Doordat de ...

    Waarschuwing | 14-04-2021