Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Cook Incorporated, 2025FA0003, Cook Beacon® Tip 5.0 Fr Angiographic Catheter

   Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.

   Waarschuwing | 19-05-2025

2. Remote Diagnostic Technologies Ltd., 2024-CC-EC-023, Tempus Pro

   Het apparaat start mogelijk niet normaal op, loopt vast of start opnieuw op. Er kunnen foutmeldingen worden weergegeven, waardoor ...

   Waarschuwing | 14-05-2025

3. Remote Diagnostic Technologies Ltd., 2024-CC-EC-042, Tempus Pro

   Wanneer een gebruiker de videolaryngoscoop (VL) tijdens het opstarten aansluit op de Tempus Promonitor, wordt het VL-scherm ...

   Waarschuwing | 14-05-2025

4. Welch Allyn, Inc., FA-2025-007, Connex Integrated Wall System; Connex Spot Monitor; Connex Vital Signs Monitor; Spot Vital Signs 4400 Device; Green Series 777 Wall System; DuraShock Aneriod Gauge Sets with a Reusable Blood Pressure Cuff; 2 Piece Reusable Blood Pressure Cuff Kits

   Baxter Healthcare Corporation is issuing a voluntary product recall for reusable blood pressure cuffs because the product is ...

   Waarschuwing | 06-05-2025

5. LeMaitre Vascular, Inc., CAPA 2025-007, TufTex® Over-the-Wire Embolectomy Catheter, Pruitt® Occlusion Catheter, Pruitt® Irrigation Occlusion Catheter

   Inadequate Tray Seals were found on samples from these three product lines.

   Waarschuwing | 28-04-2025

6. Cook Incorporated, 2025FA0002, Tornado® Embolization Microcoil™

   Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.

   Waarschuwing | 24-04-2025

7. Welch Allyn, Inc., FA-2025-009, Welch Allyn Connex Vital Signs Monitor (CVSM), Welch Allyn CP150 Electrocardiograph, Welch Allyn Connex Spot Monitor Accessory Power Management Stand (APM)

   Baxter Healthcare Corporation is issuing this Urgent Field Safety Correction Notice for the products listed below due to customer ...

   Waarschuwing | 22-04-2025

8. Contec Medical Systems Co., Ltd., FSCA-CMS8000, Contec CMS8000

   Onlangs heeft ons bedrijf via de FDA en CISA vernomen dat de CMS8000 patiëntmonitor de volgende kwetsbaarheden op het gebied van ...

   Waarschuwing | 18-04-2025

9. Intervascular SAS, RC044, Hemapatch Woven

   Intervascular/Getinge is providing this letter to inform you of a non-compliance in the Directions For Use (DFU), point (e) of ...

   Waarschuwing | 18-04-2025

10. SCHILLER AG, SAGQI-1082, FRED easyport

    SCHILLER AG has identified isolated cases where the FRED easyport failed routine maintenance tests due to defective IGBT modules.

    Waarschuwing | 07-04-2025