Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. STRYKER ENDOSCOPY, RA2022-2912780, 1688 Camera Control Unit (CCU)

   A software defect has been identified in the 1688 Camera Control Unit (CCU) that will cause the image on the monitor to flip ...

   Waarschuwing | 02-03-2022

2. Philips FSN-2021-IGT-BST-033 - Philips StentBoost Live R2.0 icm Philips Azurion SW R2.x

   a) Als gevolg van een onjuiste configuratie-instelling in de EPX-database van StentBoost Live stopt de opname niet automatisch ...

   Waarschuwing | 24-02-2022

3. 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

4. Mevion Medical Systems FSCA_220126 - 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 | 24-02-2022

5. SEBIA, FSN-FSCA-02-2022-01, CAPI 3 IMMUNOTYPING

   We inform you that a user of these kits highlighted an inversion between the anti-Ig M and anti-Lambda antisera. Our ...

   Waarschuwing | 24-02-2022

6. Abbott Molecular, Inc., FSN-FA-AM-FEB2022-267, Integrated Reaction Unit (IRU)

   Abbott has received complaints associated with the Alinity m Reaction Vessels (RVs) detaching from the RV Cap during transport by ...

   Waarschuwing | 24-02-2022

7. BioMérieux SA, FSN-FSCA 5537, VIDAS® CMV IgM

   BioMérieux received complaints about calibration issue observed on VIDAS® CMV IgM (ref 30205, 30205-01), Lot 1008873250 and Lot ...

   Waarschuwing | 24-02-2022

8. Mikrogen GmbH, FSN-DE/202001, ampliCube HEV 2.0 quant

   With this letter we would like to inform you about a mistake in the instructions for use of our ampliCube HEV 2.0 Quant (Art. no. ...

   Waarschuwing | 24-02-2022

9. Siemens Healthcare Diagnostics Inc, FSN-ACHC 22-02, Lithium_2 (LITH_2) reagents, Enzymatic Hemoglobin A1c (A1c_E) reagents, Calcium_2 (CA_2) reagents, Fructosamine (Fruc) reagents

   Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient ...

   Waarschuwing | 24-02-2022

10. Siemens Healthcare Diagnostics Inc, FSN-VC 22-01, Dimension Vista Magnesium Flex reagent cartridge

    Siemens Healthineers has confirmed that the Dimension Vista Magnesium (MG) Flex reagent cartridge lots listed in Table 1 may show ...

    Waarschuwing | 24-02-2022