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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 Device Recall Liko AB Uno Lifts see related information
Date Initiated by Firm November 11, 2008
Date Posted January 27, 2009
Recall Status1 Terminated 3 on February 04, 2016
Recall Number Z-0605-2009
Recall Event ID 50155
Product Classification Non-Ac-Powered Patient Lift - 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 MA 02038-3159
For Additional Information Contact
508-553-3993
Manufacturer Reason
for Recall		 Actuator of the lift has the potential to separate when the upper arm is fully extended.
FDA Determined
Cause 2		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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