Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. 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

3. 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

4. PendraCare International B.V., 23-001, Convey Guiding Catheter

   The purpose of this letter is to notify you that PendraCare International B.V. is conducting a voluntary field action/removal for ...

   Waarschuwing | 29-08-2023

5. Thoratec Corporation, FA-Q323-HF-3, Apical Coring Knife

   Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife could result in an ...

   Waarschuwing | 29-08-2023

6. Covidien IIc, FA1355, Palindrome Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8 mm) x 23 cm

   Bij analyse na het in de handel brengen werd vastgesteld dat bij sommige kathetersets in vier (4) specifieke loten van de ...

   Waarschuwing | 28-08-2023

7. Datascope Corp., 2249723-06.02.2023-014-C, Cardiosave Intra-Aortic Balloon Pumps

   Datascope/Getinge identified that 182 of these complaints were directly related to the IABP and described failure mode.

   Waarschuwing | 18-08-2023

8. Datascope Corp., 2249723-06.02.2023-010-C, Cardiosave Intra-Aortic Balloon Pumps

   Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and ...

   Waarschuwing | 18-08-2023

9. Datascope Corp., 2249723-06.02.2023-009-C, Cardiosave Intra-Aortic Balloon Pumps

   Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and ...

   Waarschuwing | 17-08-2023

10. St. Jude Medical, FA-Q123-SH-2 Trifecta, Trifecta Valve, Trifecta Valve w. Glide Technology

    Op 27 februari 2023 heeft Abbott al laten weten dat de mogelijkheid van Structural Valve Deterioration (Structurele ...

    Waarschuwing | 14-08-2023