Events

Rappel de Stryker Secure II MedSurg bed

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
    52230
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2216-2009
  • Date de mise en oeuvre de l'événement
    2009-08-10
  • Date de publication de l'événement
    2009-09-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82586
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Cause
    The backrest of the bed may not stay in an upright position (may drift down when left raised).
  • Action
    Stryker Medical issued an "Urgent - Medical Device Correction" letter dated August 10, 2009 informing customers to locate the affected product listed and verify whether it is functioning properly. In the case the device is not properly functioning, remove from service and contact the firm as soon as possible at 1-800-STRYKER, option 3. Customers are also asked to return an enclosed return receipt post card and also forward the notification to users who have loaned or purchased the device. A representative from Stryker field service will be contacting you to perform device corrections shortly. For further information, contact Stryker Medical at 1-269-324-6527.

Device

Stryker Secure II MedSurg bed
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, Brazil, Canada, Chile, China, India, Korea, Latin America, Mexico, Singapore and Switzerland.
  • Description du dispositif
    Stryker Secure II MedSurg bed, 230 v, Stryker Medical, Portage, MI; Model 3221. (Note: Not distributed in the US) || Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.
  • 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