Events

Rappel de Device Recall Stryker inTouch Zoom Critical Care

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 Medical Div. of Stryker Corporation.

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
    45445
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0357-2008
  • Date de mise en oeuvre de l'événement
    2007-11-02
  • Date de publication de l'événement
    2007-12-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65552
  • 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
    Hospital Bed - Product Code FNL
  • Cause
    Multiple defects: 1) beds exhibit reverse motions when the fowler, gatch or foot section is activated 2) a battery charging defect which may result in a depletion of battery power 3) the touch screen on the footboard freezing, resulting in controls to powered, pressure-relief mattresses being difficult to access 4) beds equipped with zoom drive systems may have an overdrive problem which could re.
  • Action
    Consignees were notified via an Urgent Medical Device Correction letter dated 11/2/07, and instructed to remove the beds from service if they display any unintended motions and informed that one of the firm's field service representatives will visit the facility to make corrections to all beds under recall.

Device

Device Recall Stryker inTouch Zoom Critical Care
  • Modèle / numéro de série
    All units. (Model Number 2140/Serial Numbers: T01121, T01205, T01350, T01213 thru T01214, T01224, T01014 thru T01036, T01143, T01227, T01211, T01379 thru T01383, T01202, T01053 thru T01099. T01100 thru T01144, T01159, T01179, T01182, T01378, T01186, T01201, T01212, T01057, T01060,T01079,T01200, T01183, T01189, T01223, T01209, T01218, T01172, T01188, T01058, T01171, T01173, T01195, T01203, T01206, T01210, T01216, T01217, T01228, T01176, T01185, TO1193, T01207, T01225, T01215, T01229, T01187, T01311 thru T01320, T01230, T01175, T01180, T01190, T01196, T01037 thru T01052, T01198, T01184, T01192, T01177, T01194, T01204, T01219, T01199, T01191, T01226, T01181, T01197, T01222, T01231 thru T01308,T01208, T01349, T01221, QT01001 thru QT01012, QT01169 and QT01170)
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide-USA and Canada
  • Description du dispositif
    Stryker inTouch Zoom Critical Care bed, Model 2140, Stryker Medical, Portage, MI 49002
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation

Manufacturer

Stryker Medical Div. of Stryker Corporation
  • Adresse du fabricant
    Stryker Medical Div. of Stryker Corporation, 3800 E. Centre Ave., Portage MI 49002
  • Source
    USFDA