Events

Rappel de Device Recall S3 Med/Surg 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 Division 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
    66468
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0618-2014
  • Date de mise en oeuvre de l'événement
    2013-11-26
  • Date de publication de l'événement
    2013-12-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-05-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122453
  • 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
    Stryker medical has identified a potential issue associated with secure ii and s3 med/surg beds built between april 2nd, 2005 and july 26th, 2011. the affected beds have the potential to experience damage to the foot end cover and/or power coil cable due to reduced clearance between the foot end cover and foot end lift header.
  • Action
    Stryker Medical sent an Urgent Medical Device Recall Notification letter on November 26, 2013, to all affected customers. The notification included the products being recalled, the product description, product issue, potential hazards, and actions needed. Customers were instructed to locate and inspect the beds listed in the notice and ensure that no damage has occurred to the foot-end cover, power coil cable, or sensor coil cable. If the beds were not damaged customers may continue to use them. If damage occurred, customers wsere instructed to remove the beds from service and contact Stryker at 1-800-327-0770, Option 2, then Option 2 to arrange a service call. Continue to inspect the foot-end cover and coil cables as part of their routine preventive maintenance. Customers were instructed to fax the enclosed business reply form to 269-488-8691 or email productfieldaction@stryker.com. Customers were instructed to forward the letter if the product was loaned or sold to other customers. If any beds were disposed of and were no longer in use, customers should advised Stryker by providing them with the serial number. Questions or concerns are directed to Stryker Customer Service at 1-800-327-0770. Consignees are to fax (269-488-8691) or email (productfieldaction@stryker.com) the business reply form to confirm receipt of this notification. For questions regarding this recall call 269-324-6609.

Device

Device Recall S3 Med/Surg Bed
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, China, Argentina, Brazil, Germany, Korea, Mexico, Singapore, UK, Europe, Middle East, Africa, and Latin America.
  • Description du dispositif
    S3 Med/Surg Bed || Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal differences between the functionality of the two models, each of which function as a highly complex system of a large number of individual components.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Adresse du fabricant
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA