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U.S. Department of Health and Human Services

Class 2 Device Recall Patient Scales

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  Class 2 Device Recall Patient Scales see related information
Date Initiated by Firm December 13, 2012
Date Posted April 17, 2013
Recall Status1 Terminated 3 on March 12, 2015
Recall Number Z-1128-2013
Recall Event ID 64698
Product Classification Scale, patient - Product Code FRW
Product 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.
Code Information Serial numbers: 1005 thru 1780, 1785 thru 1809, 1866 thru 1868 and 1870 thru 1875.
Recalling Firm/
Manufacturer		 Sr Instruments Inc
600 Young St
Tonawanda NY 14150
For Additional Information Contact
716-693-5977
Manufacturer 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.
FDA Determined
Cause 2		 Use error
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.
Quantity in Commerce 806 patient scales
Distribution USA Nationwide Distribution in the state of Texas.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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