Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Covidien llc, FA1370, McGrath MAC Video Laryngoscope

   Medtronic is issuing this notification to inform the public of stolen defective  McGRATH™ MAC video laryngoscopes that have been ...

   Waarschuwing | 04-10-2023

2. Seffiline S.R.L., SEFFIHAIR 3.1-SEFFICARE 3.1-SEFFIGYN 3.1-SEFFILLER 3.1 Seffiline S.r.l.

   During the assembly of the kits, two transfers for luerlock syringes supplied by a supplier other than the one qualified by ...

   Waarschuwing | 03-10-2023

3. Atrium Medical Corporation, 3011175548-08.18.2023-001-C, Atrium Ocean Water Seal Chest Drains

   The Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution ...

   Waarschuwing | 03-10-2023

4. Masimo Corporation, TC-I Reusable Tip Clip Sensor; MDSS ref: MDD23.148, TC-I Reusable Tip Clip Sensor

   Masimo identified TC- I Reusable Tip Clip sensors with higher than expected variability in SpO2 readings that are outside of the ...

   Waarschuwing | 03-10-2023

5. MAQUET Cardiovascular, LLC, 2242352-09/06/2023-004-R, MAQUET ACROBAT-i Vacuum Stabilizer System

   Maquet/Getinge is initiating a voluntary Medical Device Removal for the Acrobat-i Vacuum Stabilizer System due to a risk of the ...

   Waarschuwing | 03-10-2023

6. Fresenius Medical Care AG & Co. KGaA, SO-2023-3858, stay safe Disinfection Cap

   Fresenius Medical Care werkt de etikettering van onze stay-safe desinfectiekap bij. Tot de bijgewerkte etiketten behoren extra ...

   Waarschuwing | 03-10-2023

7. GE Healthcare Finland Oy, FMI 36160, Frame F2-01

   GE HealthCare is op de hoogte van een mogelijke onderbreking in de datacommunicatie tussen de E-modules die in het F2-01 frame ...

   Waarschuwing | 03-10-2023

8. Olympus Medical Systems Corporation, QIL FY24-EMEA-18-FY24-OMSC-24, Thunderbeat Type – S

   Olympus is taking this recall action after discovering that the Thunderbeat’s blue seal button may remain in the engaged ...

   Waarschuwing | 29-09-2023

9. Ace-medical Quality Management Dept., 202307-08-FSCA, AutoMer 2

   AutoMer 2 (A230214-E2MZ0000AT-1 was returned as a complaint device. Through the tests, Ace Medical found a problem with a ...

   Waarschuwing | 28-09-2023

10. Beaver Visitec International Inc, FA-23-002, Conventional Crescent Knife 2.5mm, 55 degrees

    BVI heeft feedback van een enkele klant ontvangen dat één partij van het artikelnummer 373807, conventioneel mes met gebogen ...

    Waarschuwing | 28-09-2023