Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Siemens Healthcare GmbH-UI XP004/19/S (FSN) and XP006/19/S (FSCA) - UROSKOP OMNIA and UROSKOP OMNIA MAX

   This letter is to inform you of a potential problem and hazard to persons when positionirig the monitors of the monitor support ...

   Waarschuwing | 27-02-2019

2. Protek Medical Products, 03/2017, Sterile disposable endocavity needle guide

   In two instances the disposable needle guide identified above, used for prostate biopsy, were found to have a loose tube when ...

   Waarschuwing | 17-03-2017

3. Olea Medical VIG-OM 19_01- Olea Sphere V3.0

   Given the relative novelty of SMS/multi-band type of acquisition and the lack of consensus in the current state of the art about ...

   Waarschuwing | 18-04-2019

4. Siemens Healthcare GmbH, AX005/23/S (FSCA), AX034/23/S (FSN), Artis zee / Q / Q.zen

   We have already informed you with CSI AX006/20/S of a possible issue with your Artis system related to the tube cooling unit and ...

   Waarschuwing | 06-05-2024

5. PTW Freiburg, QR 251-2023, Software VERIQA

   If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma ...

   Waarschuwing | 02-02-2024

6. Ion Beam Applications S.A. (IBA S.A.), NCIPT-14782, ProteusPLUS, ProteusONE

   The Orion Patient Positioning System (PPS) manufactured by Bizlink and integrated to the IBA Proton Therapy System – Proteus 235 ...

   Waarschuwing | 17-10-2023

7. PTW Freiburg, FSN-QR 168-2023, Software BeamAdjust

   In a relative calibration of the detector array, the algorithm takes the dose for each measurement chamber of the array from the ...

   Waarschuwing | 13-06-2023

8. 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

9. Field Safety Notice: HS Hospital Service SpA, RF Amica Probe

   A possible error in packaging can be present on code RFH17200E20V1 lot number 27617 and RFH17150E35V1 HS lot 27616 Fabrikant: HS ...

   Waarschuwing | 20-02-2017

10. GE Healthcare FMI 12246 - Discovery IGS 730, Discovery IGS 740

    De betrokken Discovery-systemen kunnen meerdere röntgenfouten genereren tijdens een realtime, interventionele procedure. Dit ...

    Waarschuwing | 26-04-2016