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U.S. Department of Health and Human Services

Class 2 Device Recall Liko AB Uno Lifts

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 Class 2 Recall
Liko AB Uno Lifts
see related information
Date Posted January 27, 2009
Recall Status1 Open
Recall Number Z-0605-2009
Recall Event ID 50155
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product Liko AB Uno Lifts, Powered (non-AC) Patient Lift: Uno 100 EM/EE: S/N 7090001 through 7096200 Uno 101: S/N 10001 through 11000 Production Dates: Manufactured prior to June 26, 2008 Uno 100 and 102 are battery powered mobile lifts, designed to be used in most of the common lifting situations, for example transfers between bed and wheelchair, to and from the toilet and bathtub or for lifting to and from the floor.
Code Information Uno 100: S/N 7090001 through 7096200 Uno 101: S/N 10001 through 1000 Production Dates: Manufactured prior to June 26, 2008
Recalling Firm/
Manufacturer
Liko North America Inc
122 Grove St
Franklin, Massachusetts 02038-3159
Manufacturer Reason
for Recall
Actuator of the lift has the potential to separate when the upper arm is fully extended.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Hill Rom notified customers with a Field Safety Notice, dated December 5, 2008 to notify customers of the issue, potential risks, and to inspect units per their instructions and remove units from service if the unit fails inspection. Hill-Rom will provide a permanent fix, using an "OuterTube" to be placed on all units.
Quantity in Commerce 24070 total units
Distribution Worldwide Distribution --- including USA and country of Canada.
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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