Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. SYMATESE, FSN-HEM/PAN-21-001-V2, PANGEN® and HEMOTESE®

   Several complaints have been registered by SYMATESE following a difficulty encountered when opening the external pouch of ...

   Waarschuwing | 27-06-2023

2. Philips Medical Systems Nederland BV, 2023-IGT-BST-008, Philips Azurion Philips Allura Xper

   Philips heeft vastgesteld dat als gevolg van de krachten die worden uitgeoefend tijdens de beweging van de C‐boog van de Azurion‐ ...

   Waarschuwing | 19-06-2023

3. Philips Goldway Shenzhen Industrial Inc., 2023-CC-EC-009-IR, Philips HeartStart Intrepid Monitor.Defibrillator

   Philips received complaints stating that the HeartStart Intrepid Monitor/Defibrillator encountered an issue after implementation ...

   Waarschuwing | 19-06-2023

4. Datascope Corp. Getinge, 2249723-05.05.2023-008-C, Cardiosave Intra-Aortic Balloon Pumps

   There have been reports of IABP units losing the ability to charge batteries in one or both bay slots due to a failure in the ...

   Waarschuwing | 16-06-2023

5. Medtronic B.V., FA1265, HeartWare Ventricular Assist Device HVAD System

   Het doel van deze brief is om u te informeren dat de wijziging van de batterijconfiguratiemodus om het probleem van elektrische ...

   Waarschuwing | 16-06-2023

6. Spacelabs Healthcare Inc., FSN-3010157426-03/02/2023-00001-C, Spacelabs Ultraview SL Command Module, Model 91496

   Spacelabs Healthcare is op de hoogte gebracht van verwarring die is ontstaan bij het gebruik van de functie Verwerking ...

   Waarschuwing | 13-06-2023

7. Intervascular SAS, FSN-RC041, HEMAGARD KNITTED Bifurcated grafts

   Following an internal non-conformity report, a textile defect was identified within the body of an Hemagard Knitted bifurcated ...

   Waarschuwing | 13-06-2023

8. Olympus Medical Systems Corporation, QIL FY24-EMEA-03-FY23-OMTA-35-HX-202-LRUR, SINGLE USE REPOSITIONABLE CLIP HX-202LR.UR

   Olympus has become aware of increased complaints on clip deployment occurring during clinical procedures, leading to hazardous ...

   Waarschuwing | 07-06-2023

9. Cook Endoscopy.Wilson Cook Medical Inc., 2023FA0006, Hemospray Endoscopic Hemostat

   Adhesion of the powder to the endoscope or endoscope to the tissue can result in delay in treatment, mucosal tear, perforation, ...

   Waarschuwing | 31-05-2023

10. Philips Medizin Systeme Boblingen GmbH, FSCA 2023-CC-HPM-006, Patient Information Center iX

    Philips has become aware of a potential compliance issue with the Philips Patient Information Center (PIC iX) and IntelliVue MX40 ...

    Waarschuwing | 25-05-2023