Events

Rappel de Device Recall Stryker Epic Zoom Critical Care 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
    61054
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1353-2012
  • Date de mise en oeuvre de l'événement
    2012-03-12
  • Date de publication de l'événement
    2012-03-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107181
  • 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 determined that units manufactured between september 1, 2004 through november 30, 2007, did not receive updated preventive maintenance information. (failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical int.
  • Action
    Stryker Medical sent an Urgent-Medical Device Correction letter dated March 12, 2012 to all consignees. The letter identified the affected products, problem, updated preventive maintenance information and requested the following immediate actions: 1) Locate the beds listed in this notice, 2) Ensure that the brakes are holding properly, 3) If the brakes are not holding, contact Stryker (1-800-327-0770, option 4) to order the maintenance parts, 3) Continue to periodically inspect brake functionality, as noted on enclosed preventive maintenance schedule/checklist, 4) Order replacement brake components, as needed, 5) Return the enclosed post card to confirm receipt of this notification, 6) 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, 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 numbers. For questions or concerns, please, contact Sandy Cliche at 269-389-6025.

Device

Device Recall Stryker Epic Zoom Critical Care 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) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of: DEDEDO GU, HAMILTON ON, SANTIAGO, SHATIN, NT , CAPITOL FEDERAL, ITAPEVI SP, ATHENS, OSAKA, SEOUL, MEXICO DF MX, MONTREUX, BALERNA, NORTH POINT, WARSZAWA, CANOVANAS, KOWLOON BAY, SINGAPORE, NEWBURY, and JOHANNESBURG.
  • Description du dispositif
    Stryker Epic Zoom Critical Care Bed -Model 2040, 115 V, 500 lbs ( 227 Kg) Stryker, Portage Mi 49002 || Product Usage: || EPIC II (model 2040) Critical Care beds is primarily used in a Critical Care environment, but may be used in Med/Surg environments.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

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