Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. Remote Diagnostic Technologies Ltd., 2023-CC-EC-005-IR, Tempus Pro

   An issue has been identified with the Tempus Pro Monitor where an error may occur during video laryngoscope use with the Tempus ...

   Waarschuwing | 04-09-2023

10. B.Braun Melsungen AG, FSCA-2023-08-21, Original Perfusor® Line

    Tijdens onze post-market surveillance-activiteiten hebben we het risico vastgesteld dat luer-connectoren loskomen van de ...

    Waarschuwing | 31-08-2023