Events

Rappel de Device Recall Power Bariatric Recliner

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 Hill-Rom, Inc..

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
    73138
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0860-2016
  • Date de mise en oeuvre de l'événement
    2016-01-20
  • Date de publication de l'événement
    2016-02-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143155
  • 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
    Chair, geriatric - Product Code FRJ
  • Cause
    The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury.
  • Action
    Hill-Rom sent an Urgent Field Safety Notice by POD (Proof of Delivery) mailing on January 20, 2016, to all affected customers.. The notice identified the product, the problem, and the action to be taken by the customer. Customers willl be contacted for appointments to update the power chairs with missing linkage side shields. Hill-Rom will be installing the missing linkage side shields to the Hill-Rom P9096 Power Bariatric Recliner to address this issue. Customers were instructed to ensure patients and others do not insert an appendage into the foot rest linkage mechanism during opening or closing. Customers may contact Hill-Rom Technical Support at 800-445-3720, if they have any questions.

Device

Device Recall Power Bariatric Recliner
  • Modèle / numéro de série
    Bariatric Power Recliner, Product Model # P9096; all power bariatric chairs that are affected by this field action is distributed within the following serial number range:  L341RW9151 through P070RW0812
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, WY, VA Medical Center and Internationally to Canada and Mexico. **Consumer Recommended Depth - Consumers/User**
  • Description du dispositif
    Hill-Rom Bariatric Power Recliner, Product Model # P9096 || Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Adresse du fabricant
    Hill-Rom, Inc., 1069 State Road 46 E, Batesville IN 47006-7520
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA