Events

Recall of Device Recall IMS Patient scale

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integrated Measurement Systems, Inc..

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
    37774
  • Event Risk Class
    Class 2
  • Event Number
    Z-0921-2007
  • Event Initiated Date
    2007-01-30
  • Event Date Posted
    2007-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51503
  • 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
    Patient Scale (Patient Lift) - Product Code FRW
  • Reason
    Patient scale may become detached, which can cause a patient to fall and result in injury.
  • Action
    The scale manufacturer, IMS, in conjunction with the lift manufacturer, Joerns Healthcare (previously Sunrise Medical), will initiate a field fix strategy consisting of shipping replacement 4-point cradles without scales, for use until a replacement can be designed, tested and validated. Joerns will utilize their Customer Service Help Line (1-800-826-0270) on behalf of IMS, to inform customers of the voluntary field correction, address any questions regarding the IMS scale field fix strategy and to provide additional information on return of affected IMS Patient Scales. Customers were notified by telephone beginning on January 30, 2007.

Device

Device Recall IMS Patient scale
  • Model / Serial
    All serial numbers for Model No. HOY-4PTWSC and HOY-STATUREWSC
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4pt-WSC and HOY-StatureWSC
  • Manufacturer
    Integrated Measurement Systems, Inc.

Manufacturer

Integrated Measurement Systems, Inc.
  • Manufacturer Address
    Integrated Measurement Systems, Inc., 440 Bonnie Ln, Elk Grove Village IL 60007-1908
  • Source
    USFDA