Recall of Device Recall Patient Scales

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sr Instruments 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
    64698
  • Event Risk Class
    Class 2
  • Event Number
    Z-1128-2013
  • Event Initiated Date
    2012-12-13
  • Event Date Posted
    2013-04-17
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2015-03-12
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Scale, patient - Product Code FRW
  • Reason
    Sr instruments inc. is implementing a field correction for the joerns healthcare patient lifts after they received two incident reports regarding two field failures of a tensile type load cell involving the fg3105 patient scale. the failures resulted in patient falls.
  • Action
    SR Instruments, Inc. sent a Notification letter dated December 13, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions call 716-693-5977.

Device

  • Model / Serial
    Serial numbers: 1005 thru 1780, 1785 thru 1809, 1866 thru 1868 and 1870 thru 1875.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the state of Texas.
  • Product Description
    SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. || Product Usage: || The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected between the patient hoist mechanism and patient sling apparatus. The scale is not intended to be used for patient transport.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Sr Instruments Inc, 600 Young St, Tonawanda NY 14150
  • Manufacturer Parent Company (2017)
  • Source
    USFDA