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U.S. Department of Health and Human Services

Class 2 Device Recall Liko Universal Patient lift

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 Class 2 Recall
Liko Universal Patient lift
see related information
Date Posted September 20, 2008
Recall Status1 Open
Recall Number Z-2319-2008
Recall Event ID 48747
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product Universal SlingBar 450 with Quick-release Hook Product Number: 3156085 Used in combination with all lifts from Liko, i.e. mobile lifts and overhead lifts
Code Information Affected serial numbers on sling bars: 1200101-1245680, 121204-121499, and 12222407-12225241
Recalling Firm/
Manufacturer
Liko AB
Alvik 7555
Lulea
For Additional Information Contact Ann Jordan
508-553-6642
Manufacturer Reason
for Recall
A component securing the Universal SlingBar to the patient lift, may experience a nut unthreading resulting in the sling bar detaching from the lift causing the patient to fall.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Liko North America ,the US Distributor, notified accounts by letter dated June 30, 2008 and provided a Field Safety Notice with Safety Inspection Procedures to performed on the lift prior to use. Replacement slingbars are being provided. If you have questions, contact the Liko product distributor in your country. Contact information can be found at www.liko.com/int/distributors.asp.
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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