Z-1128-2013Class II

SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient...

Name: Z-1128-2013 SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient...
Creator: Sr Instruments Inc
Published: 2012-12-13
License: https://open.fda.gov/license/

Sr Instruments Inc / initiated 2012-12-13 / Terminated

FDA source

Sr Instruments Inc began a recall of SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is... on 2012-12-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1128-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-13
Posted: 2013-04-17
Terminated: 2015-03-12
Recalling firm: Sr Instruments Inc
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.
Product code: FRW Scale, Patient
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 root cause: 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.
Product codes and lots: Serial numbers: 1005 thru 1780, 1785 thru 1809, 1866 thru 1868 and 1870 thru 1875.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1128-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1128-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-16

Product code FRW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)