Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Cordis Corporation Cordis20210720-EMEA - SUPER TORQUE® MB Angiographic Catheter

   Cordis has identified that the SUPER TORQUE® MB Angiographic Catheter (with Marker Bands) are being used in a manner that may ...

   Waarschuwing | 04-08-2021

2. Philips FCO78100527 - Ingenia (various) + SmartPath to dStream

   Philips heeft een probleem vastgesteld waardoor de tafel vast kan komen te zitten wanneer de handmatige modus alleen wordt ...

   Waarschuwing | 20-07-2021

3. GE Healthcare Europe GmbH, FSN-FMI 60978, SIGNA PET/MR - 58250 - PET/MR all others - 37654 - MRI system, full-body, superconducting magnet

   Incorrect Image Annotation and/or Flipped Images as a result of Inadvertently Changing the Prescribed Patient Orientation. SIGNA ...

   Waarschuwing | 02-07-2021

4. Varex lmaging Group Nederland B.V., FSN-CAR 3343-FSCA, Optica 30

   With this letter Varex lmaging Group Nederland B.V. would like to inform you about a possible safety issue with product Optica 30.

   Waarschuwing | 02-07-2021

5. Arcoma AB, FSN-210525C01, 0072/Precision

   Urgent Field Safety Notice Precision Risk (Stationary basic diagnostic x-ray system, digital).

   Waarschuwing | 16-06-2021

6. IBA Ion Beam Applications, FSN-PR118514, ProteusPLUS, ProteusONE

   Urgent Field Safety Notice Regarding Proteus235. Proteus235 users may be misled by the popup message displayed by the Proton ...

   Waarschuwing | 10-06-2021

7. Siemens Healthcare AX063_20_S - Artis pheno systems with SW VE10B

   In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging PERISTEPPING/PERIVISION), ...

   Waarschuwing | 26-05-2021

8. IBA (Ion Beam Applications), FSN-PR 118823, ProteusPLUS

   Urgent Field Safety Notice Regarding Proteus235: The Proton Therapy System does not prevent irradiation if the user forgets to ...

   Waarschuwing | 25-05-2021

9. Philips Medical Systems Nederland B.V., FSN-FSCA FCO781 00524, Ingenia Ambition X, Ingenia Ambition S

   URGENT veiligheidsbericht Ingenia Ambition X, Ingenia Ambition S: Probleem met mechanische afmetingen van hijsblokken boven op de ...

   Waarschuwing | 25-05-2021

10. Philips Medical Systems Nederland BV, FSN-2020-IGTBST-017, Philips Allura Xper.

    Philips Healthcare heeft door middel van trendanalyse een toename van het aantal storingen ontdekt van bepaalde DC-voedingen met ...

    Waarschuwing | 07-05-2021