Events

Rappel de Device Recall Stryker Electric Stretcher, Model 1050.

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
    51223
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1230-2009
  • Date de mise en oeuvre de l'événement
    2009-02-27
  • Date de publication de l'événement
    2009-04-05
  • 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=79310
  • 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
    Wheeled Hospital Stretcher - Product Code FPO
  • Cause
    The head section backrest (fowler) may not raise up, or, if up, may drop suddenly due to wearing out of the actuator threads on the fowler.
  • Action
    Consignees were notified by an Urgent - Medical Device Correction letter dated 2/27/09, advised of the problem and instructed to locate stretchers and verify that there is no grinding noise when activating the fowler electrically. Consignees were also instructed to remove any stretchers with a fowler that was non-operational, or which makes a grinding sound, from service until the firm makes repairs and contact the firm. Stretchers will be corrected within the next four months by a Stryker field service representative. The enclosed post card should be returned to confirm receipt of the notification. The notice should be forwarded to any users that have borrowed or purchased the stretchers and the firm should be notified of their new location. Also, if any of the affected stretchers have been disposed of or are no longer in use, the firm needs to be provided with their serial numbers. Questions or concerns should be directed to Andrea Kuthe at 269-324-6581.

Device

Device Recall Stryker Electric Stretcher, Model 1050.
  • Modèle / numéro de série
    Serial numbers 94113214, 94113215, 94113216, 94113217, 94113218, 94113219, 94113220, 94113221, 94113222, 94113223, 94113224, 94113225, 94113226, 94113227, 94113228, 94113229, 94113230, 94113231, 94113232, 94113233, 94113234, 94083551, 94083552, 94083553, 94083554, 94083555, 94083556, 94083557 A, 94083558, 94113211, 9501031208, 9501031209, 9501031210, 9501031211, 9503032237, 9503032238, 9503032239, and 9503032240.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    Stryker Electric Stretcher with the Quick Drop CPR option, Model 1050.
  • 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