Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

249 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Haemonetics Corporation, FSN-FSCA-FY21-02, Blood Collection Systems and Filters

    Haemonetics is correcting the expiry date on product certificates for a number of products where the expiry date on the product ...

    Waarschuwing | 22-02-2021

  2. Schwarzer Cardiotek GmbH FSCA #2967 - evolution core

    The ECG waveforms are received as a stream from the amplifier by the online application. There the assignment to the individual ...

    Waarschuwing | 16-02-2021

  3. Terumo BCT Inc., FSN-FA38, Spectra Optia Apheresis System

    Terumo Blood and Cell Technologies heeft klachten ontvangen van drie klanten over bijwerkingen tijdens continue mononucleaire ...

    Waarschuwing | 10-02-2021

  4. Bard Peripheral Vascular Inc, FSN-PI-21-3959, Bard® MARQUEE® Disposable Core Biopsy Instrument

    BD geeft dit bericht inzake de veiligheid in het veld uit om specifieke lots van BARD® MARQUEE® Disposable Core ...

    Waarschuwing | 10-02-2021

  5. Gambro Lundia AB, FSN-FA-2021-005, Prismaflex Control Unit

    Healthcare Corporation is issuing a Device Correction to the user level for the Prismaflex Control Unit due.

    Waarschuwing | 01-02-2021

  6. Medtronic, Inc., FSN-FA952, Strata II, Delta and Flow Control Valve

    Het doel van deze brief is u te informeren over een mogelijke variatie in zichtbaarheid van radiopaque markeringen tijdens ...

    Waarschuwing | 15-01-2021

  7. Baxter Healthcare SA, FSN-FA-2020-065, PRISMAX, V2 ROW

    Baxter Healthcare Corporation is issuing a Device Correction for the PrisMax System due to inconsistent variability of the tubing ...

    Waarschuwing | 11-01-2021

  8. Baxter Healthcare SA, FSN-FA-2020-064, PrisMax, V2, ROW

    Baxter Healthcare is issuing a Safety Alert for the PrisMax System.

    Waarschuwing | 11-01-2021

  9. GAMBRO DASCO, FSN-FA-2020-068, Haemodialysis tubing set single-use

    Baxter Healthcare Corporation has received customer reports of kinked access lines observed during treatment using cartridge sets ...

    Waarschuwing | 06-01-2021

  10. Maquet_Getinge FSCA-2020-12-07 - Pediatric Venous Hardshell Cardiotomy Reservoir

    During verification testing of Pediatric VKMOs and VHKs a potential impairment of the sterile packaging barrier system was ...

    Waarschuwing | 16-12-2020