Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Maquet Cardiopulmonary GmbH, 874275, Custom Tubing Packs

   It was reported that there was gas leaking from the cardioplegia line.

   Waarschuwing | 31-10-2023

2. St. Jude Medical, FA-Q323-HF-4, CardioMEMS Patient Electronic System

   Abbott heeft vastgesteld dat de voedingsaansluiting beschadigd kan raken als hii verder dan 90 graden gebogen wordt. De ...

   Waarschuwing | 17-10-2023

3. Boston Scientific Corporation, 98973760-FA, Guider Softip XF Guide catheters

   Stryker Neurovascular has observed that certain lots of Guider Softip™ XF Guide Catheters appear to have the incorrect tip curve ...

   Waarschuwing | 13-10-2023

4. 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

5. 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

6. Cardiac Pacemaker Inc, 92892652-FA, EMBLEM™ S-ICD and EMBLEM™ MRI S-ICD

   Belangrijke software-update voor EMBLEM™ subcutane implanteerbare cardioverter-defibrillatoren (S-ICD’s) als oplossing voor ...

   Waarschuwing | 19-09-2023

7. Philips Medizin Systeme Böblingen GmbH, FSCA 2023-CC-HPM-027, Patient Information Center iX

   Philips has become aware of a potential safety issue with the Patient Information Center (PIC iX) Release 4.x where Surveillances ...

   Waarschuwing | 14-09-2023

8. Berlin Heart GmbH, DS-23-01, EXCOR Cannula

   Berlin Heart dringt er bij u op aan om goed op de integriteit van de canule te letten en op situaties waarbij onjuist gebruik of ...

   Waarschuwing | 14-09-2023

9. St. Jude Medical Cardiac Rhythm Management Division FA-Q122-CRM-2, Gallant™ device

   An electrical circuit component in these devices may have a rare issue, which if present, will disable Bluetooth telemetry and, ...

   Waarschuwing | 12-09-2023

10. Maquet Cardiopulmonary GmbH, 626803, CARDIOHELP-i

    Insufficient securement of the slide rails to the lateral aspects to CARDIOHELP could provide an opportunity of both/either the ...

    Waarschuwing | 08-09-2023