Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Stryker Medical/ Technologies LLC, RA2023-3293631, HeartSine samaritan® PAD

   Stryker is conducting a voluntary recall as we have determined that the affected Pad-Paks may be rendered inoperable due to ...

   Waarschuwing | 14-09-2023

2. Olympus Medical Systems Corporation, Disposale EMR Kit

   Since Olympus has confirmed that alternative products can be provided, Olympus has decided to ask our customers to cease using ...

   Waarschuwing | 14-08-2023

3. QIAGEN GmbH, FSN-CI 3028397, QIAstat-Dx® Respiratory SARS-CoV-2 Panel

   Deze dringende veiligheidsmededeling dient om u erover te informeren dat QIAGEN heeft vastgesteld dat bepaalde partijen van de ...

   Waarschuwing | 08-06-2023

4. HS Doms GmbH, C-126, Ecocentric.HS-810

   At testing of the refraction unit, a non-compliance with the EN 60601-1 standard was determined.

   Waarschuwing | 04-05-2023

5. Medtronic, FA1324, Neuroscience CST StealthStation S7 Cranial Software v3.1.4

   This notification is to inform you of actions being taken to address two software anomalies impacting the StealthStation™ S7 and ...

   Waarschuwing | 20-04-2023

6. Samsung Electronics Co., FSN-FSCA-GM85_230228-1, Limited, GM85

   Samsung Electronics is zich onlangs bewust geworden van een potentiële kwestie met betrekking tot de werking van de ...

   Waarschuwing | 30-03-2023

7. Siemens Healthcare GmbH, FSN-AX040/22/S (FSCA), AX041/22/S (FSN), ARTIS pheno

   We would like to inform you about potential issues with your ARTIS system in combination with a Siemens Healthineers table or a ...

   Waarschuwing | 30-03-2023

8. Reproline medical GmbH, Soft Denudation Tips , Follicular Dysfunction Systems, Soft Denudation Tips + Follicle Puncture Systems

   In the course of the risk assessment, the present situation was evaluated. The embryotoxicity that may be present could cause ...

   Waarschuwing | 17-02-2023

9. MEDIPREMA, MV2022-005, FABIE AMBIA

   Please be advised that an error in use has been reported during the nursing of a newborn with a FABIE radiant incubator ...

   Waarschuwing | 09-02-2023

10. Ivor Shaw Ltd t/a Pennine Healthcare, FSN-PHFSN 2023-1, Link Yankauer Sets and Suction Connecting Tubing

    Pennine has received two customer complaints related to sterile barrier (pouch) breach. The pouches were found to be open before ...

    Waarschuwing | 26-01-2023