ClearanceBrief
Recall Z-1128-2013 ยท FRW Scale, Patient

Sr Instruments Inc

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.

DateApr 17, 2013 (initiated Dec 13, 2012)
StatusTerminated
ReasonSR 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.
Root causeUse error
ActionSR 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.
Quantity806 patient scales
DistributionUSA Nationwide Distribution in the state of Texas.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.