Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Respironics LLC, 2022-CC-HRC-013, V680 Ventilator

    The purpose of this letter is to communicate a market removal over the next six months of the Philips Respironics V680 (V680) ...

    Waarschuwing | 06-02-2023

  2. Roche Diagnostics GmbH, SBN-RDS-CoreLab-2023-001, Elecsys Troponin T hs Elecsys Troponin T hs STAT

    During internal studies with the Elecsys Troponin T hs (high sensitive) / Elecsys Troponin T hs STAT assay, discrepant elevated ...

    Waarschuwing | 06-02-2023

  3. BioMérieux SA, FSN-FSCA 5742-1, MUELLER HINTON E AGAR

    Following customer complaints, a performance limitation with the combination Pseudomonas aeruginosa - Gentamicin on MUELLER ...

    Waarschuwing | 02-02-2023

  4. Miele & Cie. KG, FSN-INC000000545062, Steelco PWD 8626 / Steelco PWD 8628

    Met deze brief willen wij u informeren over een mogelijk veiligheidsprobleem met betrekking tot de intelligente programmakeuze. ...

    Waarschuwing | 02-02-2023

  5. Drägerwerk AG & Co. KGaA, FSN-PR 126026, Flex ventilation hoses

    Due to a deviation in the manufacturing process, components of the hose material remained as particles inside the hoses. Our ...

    Waarschuwing | 30-01-2023

  6. Ivor Shaw Ltd t/a Pennine Healthcare, FSN-PHFSN 2023-1, Link Yankauer Sets and Suction Connecting Tubing

    Pennine has received two customer complaints related to sterile barrier (pouch) breach. The pouches were found to be open before ...

    Waarschuwing | 26-01-2023

  7. Angiomed GmbH & Co. Medizintechnik KG, FSN-PI-22-4559, Covera™ and Covera™ Plus Vascular Covered Stent

    Op basis van feedback van klanten heeft BD vastgesteld dat de Covera™ en Covera™ Plus beklede vasculaire stents problemen kunnen ...

    Waarschuwing | 26-01-2023

  8. Implantcast GmbH, FSN-FSCA_22002, MUTARS® HD coupling

    The reason for this product recall is that four serious incidents were fed back to us in which the MUTARS® HD coupling failed.

    Waarschuwing | 26-01-2023

  9. PlanerLimited, FSN-1216677-07-21-2022-002-R, Humidifier Bottle and Syringe filter kit for BT37

    CooperSurgical has sent a recall notification to all affected customers. The products are being recalled due to a repackaging ...

    Waarschuwing | 26-01-2023

  10. Balanced Body, Inc., FSN-FSCA-001-REFORMER, Studio Reformer

    Balanced Body has determined that when a user performs Reformer exercises in a standing or high kneeling position on the carriage ...

    Waarschuwing | 26-01-2023