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  1. Apollo Endosurgery, Inc., LLC, FSN-FSCA-20-002, BIB/Orbera/Orbera365 Intragastric Balloon Systems

    Apollo Endosurgery is conducting this Field Safety Notice to inform physicians about routine updates to the labeling on its ...

    Waarschuwing | 13-07-2021

  2. CAIR LGL RC19228 - Polyurethane enteral feeding tubes

    This phenomenon is characterized by the appearance of a non-uniform yellow color at different part on the polyurethane tubes of ...

    Waarschuwing | 13-07-2021

  3. Abbott Diagnostics FA12JUL2021 - Alinity s System

    Abbott has identified an issue with liquid waste pressure monitoring. This communication provides actions to be followed until ...

    Waarschuwing | 12-07-2021

  4. Gentherm Medical, LLC (formerly Cincinnati Sub-Zero), FSN-FA2021-003, UV Treo

    Urgent Field Safety Notice UV Treo Advanced Temperature Management System.

    Waarschuwing | 12-07-2021

  5. Stryker Joint Replacement, FSN-RA2021-2744351, Restoris® MCK Femoral Trial

    Stryker has discovered that there is a potential that the threads on the Femoral Trial Slaphammer may not engage with the threads ...

    Waarschuwing | 12-07-2021

  6. Merit Medical Systems Inc., FSN-1721504-06/07/21-005R, basixALPHA(TM)

    Merit Medical Systems, Inc. roept vrijwillig het basixALPHA™-vulinstrument terug vanwege een ontwerpfout.

    Waarschuwing | 09-07-2021

  7. Medtronic Inc. FA984 - Vectris SureScan MRI Lead kit

    Medtronic heeft vastgesteld dat specifieke PIN's van de Vectris SureScan MRI-geleidingsdraadsets onjuiste informatie bevatten ...

    Waarschuwing | 09-07-2021

  8. Olympus QIL 154-006 - Olympus Soltive Laser System

    Olympus America Inc. (“Olympus”) has recently received complaints of patient injury associated with the OLYMPUS Soltive Laser ...

    Waarschuwing | 08-07-2021

  9. W.L. Gore & Associates B.V. 3007284313.07_07_2021.001-R - GORE Molding and Occlusion Balloon Catheter

    Between April 2, 2021 and June 30, 2021, W. L. Gore & Associates, Inc. (Gore) received 75 complaints regarding GORE® Molding and ...

    Waarschuwing | 07-07-2021

  10. Gentherm Medical, LLC (formerly Cincinnati Sub-Zero),FSN-FA2021-004, Hemotherm

    DRINGENDE VEILIGHEIDSKENNISGEVING: Hemotherm 400CE koel-/verwarmingsapparaat met twee reservoirs FA2021-004 Correctie.

    Waarschuwing | 06-07-2021