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  1. BIOTECK SPA, FSCA REF: 230307, BIO-GEN/GRANULES

    The falsified devices bear the name BIO-GEN® and the indication of Bioteck SpA as the manufacturer but have packaging ...

    Waarschuwing | 29-03-2023

  2. Covidien llc, FA1310, Monopolar Curved Shears

    Deze terugroepactie is uitgevaardigd na 17 ingediende klachten met betrekking tot een kabelbreuk in de Hugo RAS monopolaire ...

    Waarschuwing | 29-03-2023

  3. IRadimed Corporation, FSN-3005053560-03/01/2023-001-C; MDSS ref.: MDD23.053, 1057 MRiduim MRI Infusion Syringe Adapter Set

    Iradimed has received reports of 1057 Syringe Adapter Sets not properly venting air into the attached syringe during use, which ...

    Waarschuwing | 25-03-2023

  4. FSCA-001, TIB Molbiol Syntheselabor GmbH, LightMix• ModularDx Sapovirus

    TIB Molbiol Syntheselabor GmbH heeft een klacht van een klant ontvangen over de LightMix® ModularDx Sapovirus set. De ...

    Waarschuwing | 25-03-2023

  5. Helena Biosciences Europe, FSN-NC661, Collagen

    This lot of Collagen has demonstrated poor aggregation response at very low doses of 1.25ug/mL

    Waarschuwing | 23-03-2023

  6. Richard Wolf GmbH, FSN-FSCA700020652, FLEX. GRASP. FORCEPS or FLEX. BIOPSY FORCEPS

    We have received complaints from users stating that the forceps can no longer be opened during use. Our investigation has shown ...

    Waarschuwing | 23-03-2023

  7. Datascope Corp., FSN-2249723-02/02/2023-005-C, Cardiosave Intra-Aortic Balloon Pumps

    Datascope/Getinge has identified that, while conducting Safety Disk testing, expired tubing was used on the test fixture ...

    Waarschuwing | 23-03-2023

  8. Philips Medical Systems Nederland BV, FSN-2023-IGT-BST-002, Philips Azurion

    Philips has become aware of a potential safety issue with the Philips Azurion System R2,2.0, R2.2.1, R2.2.3, R2.2.S and R2.2.6, ...

    Waarschuwing | 23-03-2023

  9. Maquet Cardiopulmonary GmbH, 781869, QUADROX-i.-iD, VHK 11000, VKMO 10000.11000

    Maquet Cardiopulmonary GmbH (MCP) became aware of various failure modes in regard to the QUADROX-i/ -iD, VHK 11000 and VKMO ...

    Waarschuwing | 23-03-2023

  10. Biocartis NV, FSN-BC-020988, Idylla™ Instrument Test

    In the context of a complaint investigation, Biocartis has identified a set of Instruments manufactured between September 2021 ...

    Waarschuwing | 21-03-2023