BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1128-2013 · Initiated December 13, 2012

    Recall

    Recall Number
    Z-1128-2013
    Event Number
    64698
    Firm
    Sr Instruments Inc
    FEI Number
    1317256
    Product Code
    FRW
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    December 13, 2012
    Posted
    April 17, 2013
    Terminated
    March 12, 2015
    Address
    600 Young St, Tonawanda, NY, 14150

    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.

    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.

    Distribution

    USA Nationwide Distribution in the state of Texas.

    Quantity

    806 patient scales