Events

Rappel de Device Recall Spirit One

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
    71667
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1555-2016
  • Date de mise en oeuvre de l'événement
    2015-07-02
  • Date de publication de l'événement
    2016-04-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138676
  • 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
    Customer complaints associated with faulty brake system.
  • Action
    Stryker Corp.sent an Urgent Medical Device Recall letter on July 21, 2015, via FedEx to all affected customers. The letter will identified the product the problem and the action needed to be taken by the customer. Customers are instructed the following actions: 1.Locate the units listed on the attached business reply form. 2.Remove these units from service. (Note: The original mattress purchased with the bed is not within scope of this action. The mattress will be compatible with your replacement option.) 3.Your Stryker Sales Representative will contact your facility to coordinate removal of the recalled beds and present replacement options. 4.Return the enclosed business reply form to your Stryker Sales Representative to confirm receipt of this notification or fax (269)488-8691 or email productfieldaction@stryker.com 5.If you have loaned or sold any of the beds listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. 6.If you have disposed of any of the beds and they are no longer in use, please advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form. *For additional information, please refer to the products operations and/or maintenance manuals. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If there are any questions or concerns, please contact Stryker Customer Service (1-800-327-0770) during normal business hours are Monday-Friday 8 a.m-6 p.m. (EST).

Device

Device Recall Spirit One
  • Modèle / numéro de série
    MDL#: E341062; Serial Numbers: B5A00-029643 029644 029537 029538 029539 029412 029413 029092 029093 029430 029431 029432 029433 029411 029479 029480 029463 029658 029461 029462 027773 029536 029420 029421 029423 029424 029094 029095 029096 029097 029098 029458 029459 027772 028853 028854 029563 029564 029639 029640 028835 030097 030099 028845 028846 028847 028848 029416 028003 029177 029418 029427 029428 029558 029559 029560 028834 029419 029429 029416 028840 028842 028843 028844 028836 028837 028838 028839 028849 028850 028851 028852 028841 028957 028958 028959 029460 029466 029467 029468 029415 029648 029460 029466 029645 029649 029650 029652 029654 029655 029657 029659 030096 030098 029467 029468 029656 029417 030154 030157 030158 030159 030161 030223 030225 030226 030354 030100 030152 030439; B5F00-029179 028654 028655 028656 028659 028660 028661 028663 028664 028793 028657 029540 029541 029646 029642 028788 029176 029175 029414 029178 029561 028216 029464 030151; B5C00-029182 029183 029184 029185 029186 029187 029188 029189
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : AL, AZ, FL, GA, HI, IA, IL, KS, LA, MI, MN, MO, NE, NJ, OH, PA, SC, TN and TX., and Internationally to the countries of : Canada and UK.
  • Description du dispositif
    Spirit One A-C Powered Hospital Bed
  • 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