Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Boston Scientific, 92495618-FA, Sensor Nitinol Guidewires with Hydrophylic Tip

   BSC heeft een toename in gemelde klachten voor getroffen hulpmiddelen opgemerkt, die betrekking hadden op een lastige of ...

   Waarschuwing | 19-03-2020

2. Olympus Medical Systems Corporation, FSN-QIL FY24-EMEA-10-FY24-OMSC-05, PowerSpiral Intestinal Videoscope PSF-1

   Recall - Market removal of PowerSpiral PSF-1 and associated accessories DPST-1 and PSCU Olympus had become aware of a situation ...

   Waarschuwing | 11-07-2023

3. Philips Ultrasound Inc, FSN-2023-PD-US-005, 3D9-3v Transducer

   The 3D9-3v Transducer chassis assembly consists of two parts that are bonded together. The bond between the front and rear parts ...

   Waarschuwing | 06-07-2023

4. Thoratec Corporation FA-Q321-MCS-1 HMT BLUETOOTH INTERFERENCE - HEARTMATE TOUCH™ COMMUNICATIESYSTEEM

   Abbott stuurt u deze kennisgeving om u op de hoogte te stellen dat wij klachten hebben ontvangen dat de “HeartMate Touch™ ...

   Waarschuwing | 02-11-2021

5. Medtronic Inc., FSN-FA1188, Activa Clinician Programmer Application

   The purpose of this letter is to inform you of the potential for the Medtronic model A610 DBS Clinician Programmer Tablet ...

   Waarschuwing | 16-09-2021

6. Delcath Systems Inc, FSN-HHE 2021-001, CHEMOSAT

   Delcath Systems is providing this Field Safety Notice after reports were received of the silicone valve in the 18F Sheath ...

   Waarschuwing | 09-03-2021

7. Olympus Medical Systems Corporation, FSN-QIL 153-016, Olympus TJF-Q170V &TJF-Q190V & TJF-Q290 & MAJ-2315

   The safety notice pertains to the referenced Olympus endoscope models and the disposable distal cover: DUODENOVIDEOSCOPE ...

   Waarschuwing | 11-02-2021

8. Olympus QIL 153-016 - DUODENOVIDEOSCOPE TJF-Q170_TJF-Q190V_TJF-Q290V and DISTAL COVER MAJ-2315

   Olympus has identified an increase in the number of complaints from customers reporting that mucosal tissue was found within the ...

   Waarschuwing | 11-02-2021

9. Medtronic Inc., FSN-FA949, Intellis Clinician Programmer Application

   Medtronic vaardigt vrijwillig een dringende veiligheidskennisgeving uit om te verzoeken dat u de Intellis™-softwaretoepassing ...

   Waarschuwing | 18-12-2020

10. Boston Scientific Corporation, FSN-92583333-FA, Hurricane RX Biliary Balloon Dilatation Catheter

    Boston Scientific Corporation (BSC) start de terugroepactie van specifieke lots/batches van Hurricane™ RX biliaire ...

    Waarschuwing | 16-09-2020