BEUDAMED
    FDA Enforcement Class II 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 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1128-2013
    Event ID
    64698
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sr Instruments Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    December 13, 2012
    Classification Date
    April 16, 2013
    Termination Date
    March 12, 2015
    Address
    600 Young St, N/A, Tonawanda, NY, 14150, United States

    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.

    Code Info

    Serial numbers: 1005 thru 1780, 1785 thru 1809, 1866 thru 1868 and 1870 thru 1875.

    Distribution

    USA Nationwide Distribution in the state of Texas.

    Quantity

    806 patient scales