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  1. Ameco Medical Industries, VIG-33-2023-FC03, AMECATH Short Term Haemodialysis Catheter

    Luxation of the catheter due to suture-wing detaching from catheter with lot number 21006

    Waarschuwing | 12-12-2023

  2. Stihler Electronic GmbH, #2023-11 (FSN), #2024-01 (FSCA), ASTOPAD

    SOF and COV applied parts manufactured from May 2022 to October 2023 may potentially have internal (not visible from outside) ...

    Waarschuwing | 11-12-2023

  3. ARDO medical AG, FSCA 2023-01, Master

    Some devices (Master) can overheat due to an incorrectly assembled circuit board and as a result therefore switches off. This ...

    Waarschuwing | 11-12-2023

  4. Cardiac Pacemaker Inc, 92977025-FA, Model 3120 ZOOM PRM with Model 2892 Software

    Vanaf 10 januari 2024 geeft de klokparameter die wordt gebruikt door de softwaretoepassing van Model 2892 in de Model 3120 ...

    Waarschuwing | 11-12-2023

  5. Actim Oy, 1698PARTUS, Actim Partus Test

    Our recent interference testing has shown that the presence of lubricants in the vaginal specimen may interfere with the Partus ...

    Waarschuwing | 11-12-2023

  6. Leica Biosystems Nussloch GmbH, CN-237848, Leica Biosystems Tissue processor

    As part of our post market surveillance, we have been made aware of an issue regarding poorly processed and/or damaged biopsy ...

    Waarschuwing | 11-12-2023

  7. Actim Oy, 1698PARTUS, Actim PROM Test, Actim PROM 1ngeni Test

    Our recent interference testing has shown that the presence of lubricants in the vaginal specimen may interfere with the PROM ...

    Waarschuwing | 11-12-2023

  8. LDN Labor Diagnostika Nord GmbH & Co. KG, DE/0000040010, Androstanediol-Glucuronide ELISA

    For the product AA E-1500 Androstanediol Glucuronides ELISA Lot 230083( it has been detected that the standards D (AA E-1504 Lot ...

    Waarschuwing | 08-12-2023

  9. Olympus Medical Systems Corporation, QIL FY24-EMEA-29-FY24-EMEA-14-White Tape on Scope, Olympus Flexible Endoscopes

    Olympus recently received complaints indicating that the insertion tube of a repaired endoscope was wrapped with white tape. This ...

    Waarschuwing | 08-12-2023

  10. VOSTRA GmbH, 36063/23, U473, Rhinotamp und Rhinotamp latexfrei

    As part of the PMS activities, VOSTRA has become aware of a case of use with the product RHINOTAMP in which a user pulled on the ...

    Waarschuwing | 08-12-2023