Recall Z-1128-2013— Sr Instruments Inc
Class II · Terminated
Class II FDA medical device recall by Sr Instruments Inc, initiated 2012-12-13, terminated 2015-03-12. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Sr Instruments Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-13
- Terminated
- 2015-03-12
- Firm location
- Tonawanda, NY, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.