Events

Rappel de Invacare AC-Powered Adjustable Hospital 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 Invacare 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
    56333
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2393-2010
  • Date de mise en oeuvre de l'événement
    2006-10-16
  • Date de publication de l'événement
    2010-09-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-09-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93259
  • 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
    Invacare corporation, florida issued a device correction in october 2006 for the ivc bed foot actuator used on the ivc bed series, models 5890 ivc and 5490 ivc. the actuators were not in the fully extended position and could not be mounted onto the beds. all affected consignees were notified of this correction in october 2006.
  • Action
    Invacare Corporation issued a notice of an Urgent Field Correction to Consignees on 10/18/2006. Consignees were instructed to check the serial number of their units to see if they were potentially affected. If so, the firm provided inspection and adjustment instructions of the foot actuator to prevent a likelihood of injury. After adjustment, the consignees were requested to complete and return the enclosed tracking sheet acknowledging receipt of the recall notice and correction of the bed(s). For questions or assistance regarding this correction, please contact the Customer Relationship Management Group at (800) 333-6900, or via e-mail at CRMGroup@Invacare.com.

Device

Invacare AC-Powered Adjustable Hospital Bed.
  • Modèle / numéro de série
    Models: 5890 and 5490
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed throughout the U.S.
  • Description du dispositif
    Invacare AC-Powered Adjustable Hospital Bed. || Model 5890 IVC and 5490 IVC. || Manufactured by: || Invacare Corp. 2101 East Lake Mary Blvd., Sanford, FL 32773.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Adresse du fabricant
    Invacare Corporation, 2101 E. Lake Mary Blvd., Sanford FL 32773
  • Société-mère du fabricant (2017)
    Invacare Corporation
  • Source
    USFDA