Events

Rappel de Stryker Vision 3 /Stryker Vision Elect Monitor

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Stryker Communications Corp.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    49568
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0625-2009
  • Date de mise en oeuvre de l'événement
    2008-09-02
  • Date de publication de l'événement
    2009-01-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-01-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73820
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    AC-Powered Operating-Room Table - Product Code FQO
  • Cause
    Paint chips: shroud used to cover cables on the stryker vision 3 flat panel monitor (monitor used in surgery rooms during procedures) was not manufactured/painted to specification, resulting in the possibility that paint chips could fall off and fall into non-sterile and/or sterile fields during surgery. for further information, please contact stryker communications corporation by telephone at 97.
  • Action
    Firm began notifying consignees of recall via letter on 09/02/08. Consignees advised that a representative would shortly visit the facility to replace the shroud with one that complies with specifications. The recall letter is entitled "URGENT: Device Recall."

Device

Stryker Vision 3 /Stryker Vision Elect Monitor
  • Modèle / numéro de série
    All product shipped between 06/05/06 and 01/31/07.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution; Product distributed nationwide to consignees in the states of CA, FL, IL, IN, MA, MN, NC, NM, OH and TX and to the following countries: Canada, Spain and the United Kingdom,
  • Description du dispositif
    Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked), 0682-000-415 (SV3 Shroud Retro Fit Kit) and 0682-000-416 (Flat Panel Retro Fit Kit); distributed by Stryker Communications, Flower Mound, TX 75028. The 0682-000-414 (FP Shroud version 2 reworked) is a shroud designed to cover the cabling necessary on a Stryker Version 3 Monitor when mounted on the Flat Panel Arm.
  • Manufacturer
    Stryker Communications Corp

Manufacturer

Stryker Communications Corp
  • Adresse du fabricant
    Stryker Communications Corp, 1410 Lakeside Pkwy Ste 100, Flower Mound TX 75028-4026
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA