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Recall Observatory FDA recall evidence

Device 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.

Z-1128-2013

December 13, 2012

Class II

Product summary

Firm
Sr Instruments Inc
Event
Event 64698
Status
Terminated
Classification
Class II
Quantity
806 patient scales
Official record key
device-enforcement:Z-1128-2013

Official wording

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

Distribution pattern: USA Nationwide Distribution in the state of Texas.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.