Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

153 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

Vul zoekcriteria in
Vul hier een trefwoord in waarop u wilt filteren.
Periode
U kunt hier een specifiek type publicatie kiezen, zoals brochures of jaarverslagen.
Sorteren op:
Abonneren op documenten over dit onderwerp
  1. Maquet Cardiovascular, 2242352-06/07/2024-001-R, Vasoview Hemopro Endoscopic Vessel Harvesting Sys.

    Maquet Cardiovascular, LLC (MCV), a subsidiary of Getinge, is initiating a voluntary Medical Device Removal for the VasoView ...

    Waarschuwing | 11-07-2024

  2. Olympus Europa SE & Co. KG, FY25-EMEA-09-FY23-OSTA-13-SoltiveWirelessFootswitch, Soltive Laser System

    Olympus investigated complaints received where customers reported difficulties in pairing the wireless footswitch with the ...

    Waarschuwing | 01-07-2024

  3. Maquet Cardiovascular, LLC/Getinge, 2242352-05/21/2024-001-C, VASOVIEW HEMOPRO, VASOVIEW HEMOPRO 2

    lf there is fluid ingress into the handle of the operating tool, the device may not provide cautery or may continue to provide ...

    Waarschuwing | 20-06-2024

  4. Olympus Medical Systems Corporation, HD Lightweight Pendulum Camera Head

    Olympus idenfied the repair process for 36 HD Camera Heads (CH-S200-08-LB) did not align with the manufacturing process final ...

    Waarschuwing | 17-06-2024

  5. Cook Ireland Ltd, 2024FA0002, ECHO-19: EchoTip® Ultra Endoscopic Ultrasound Needle; ECHO-HD-19-A: EchoTip® Ultra HD Ultrasound Access Needle

    Tijdens het routinematige endotoxineprogramma zijn niveaus van bacteriële endotoxine geconstateerd die buiten specificatie ...

    Waarschuwing | 16-05-2024

  6. Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY25-EMEA-01-FY23-OSTA-14-InstaClear Sheath, INSTACLEAR SHEATH

    Olympus is taking this corrective action after investigating a complaint for an InstaClear Sheath (Model # LCS4K30BTOL) in which ...

    Waarschuwing | 08-05-2024

  7. Ace Medical Devices PVT LTD, AFSCA.01.2023-00, Ace Bladder Evacuator

    Mogelijke complicaties van blaasbreuken / perforaties / scheuren in verband met het gebruik van dit apparaat zijn aan de ...

    Waarschuwing | 22-04-2024

  8. Intuitive Surgical, Inc., ISIFA2024-02-R, SureForm45/60, Cannula Seal, Arm Drape, Obturator

    Intuitive is tot de ontdekking gekomen dat er bepaalde partijen verzonden zijn die over hun officiële vervaldatum waren.

    Waarschuwing | 04-04-2024

  9. Olympus Medical Systems Corporation, QIL FY24-EMEA-38-FY24-OMSC-06, High Flow Insufflation Unit

    Olympus has become aware of an increased trend from both repairs and customer complaints of the “UHI-4 stopping CO2 gas supply ...

    Waarschuwing | 03-04-2024

  10. Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-36-FY24-OSTA-06, SOLTIVE SuperPulsed Laser System

    As part of Olympus’ post market surveillance of Soltive Laser use, including a review of customer complaints and adverse events, ...

    Waarschuwing | 27-03-2024