Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Technomed Europe, NCR 22-063, Disposable Subdermal Needle Electrode, Pt.Ir

   There are still products in the market that are accompanied with a version of the Instructions for use that does not have the MRI ...

   Waarschuwing | 12-09-2022

2. FUJIFILM medwork, CAPA-2022-031, CrossSnare

   As long as the limit values are exceeded the products might pose a small potential threat to the health of users or patients ...

   Waarschuwing | 07-09-2022

3. AAT Alber Antriebstechnik GmbH, FSN-07-22, V-MAX² P1605 Schiebe- und Bremshilfe

   From May 2021 to July 2022, motor brake units were installed in individual V-MAX² push and brake aids, some of which were not ...

   Waarschuwing | 05-09-2022

4. ChipSoft, FSN-RMT376, HiX

   Wanneer de instelling MC_ATPAR ‘MO zonder waarschuwingen ook paraferen bij accorderen’ aan staat, worden medicatieopdrachten met ...

   Waarschuwing | 11-08-2022

5. nal von minden GmbH, COM22-01022, NADAL® COVID-19 Ag+Influenza A/B plus Test

   Bij een aantal NADAL® COVID-19 Ag + Influenza A/B plus testkits uit de hierboven vermelde batch is een etiketteringsfout in de ...

   Waarschuwing | 24-06-2022

6. Dräger PR117745 - Breathing System Filter SafeStar 55

   Within our global vigilance activities, we have become aware of one case in which an obstructed breathing system filter SafeStar ...

   Waarschuwing | 01-06-2022

7. VYGON GmbH FSN 2022-001 - peelable cannula

   Na het plaatsen van de katheter en het terugtrekken van de afpelbare canule kan het in enkele gevallen gebeuren dat de canule ...

   Waarschuwing | 19-04-2022

8. Mikrogen GmbH DE/202201 - recomScan Software v3.4 (BLOTrix System)

   With this letter we would like to inform you about a defective version of recomScan 3.4 software for avidity test systems.

   Waarschuwing | 13-04-2022

9. Mevion Medical Systems, FSN-FSCA_220209, Mevion S250i

   Mevion was informed of an instance where a user changed only the Setup isocenter in ARIA in a previously approved plan, without ...

   Waarschuwing | 01-04-2022

10. NeuMoDx Molecular, a QIAGEN Company, FSN-CA-2021-006, NeuMoDx Cartridge

    QIAGEN has become aware of the potential for false positive results to occur when the above lot of cartridges are used in ...

    Waarschuwing | 24-02-2022