SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# F...
FDA Recall #Z-1128-2013 — Class II — December 13, 2012
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.
Reason for Recall
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.
Recalling Firm
Sr Instruments Inc — Tonawanda, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
806 patient scales
Distribution
USA Nationwide Distribution in the state of Texas.
Code Information
Serial numbers: 1005 thru 1780, 1785 thru 1809, 1866 thru 1868 and 1870 thru 1875.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated