Events

Recall of Invacare AC-Powered Adjustable Hospital Bed.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invacare Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56333
  • Event Risk Class
    Class 2
  • Event Number
    Z-2393-2010
  • Event Initiated Date
    2006-10-16
  • Event Date Posted
    2010-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93259
  • Notes / Alerts
    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.
  • Extra notes in the data
    Bed, Ac-Powered Adjustable Hospital - Product Code FNL
  • Reason
    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.
  • Model / Serial
    Models: 5890 and 5490
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed throughout the U.S.
  • Product Description
    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
  • Manufacturer Address
    Invacare Corporation, 2101 E. Lake Mary Blvd., Sanford FL 32773
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA