Date Initiated by Firm | November 11, 2008 |
Date Posted | January 27, 2009 |
Recall Status1 |
Terminated 3 on February 04, 2016 |
Recall Number | Z-0606-2009 |
Recall Event ID |
50155 |
Product Classification |
Non-Ac-Powered Patient Lift - Product Code FSA
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Product | Liko AB Uno Lifts, Powered (non-AC) Patient Lift:
Old Uno 102: S/N 20001 through 21300
New Uno 102 EM/EE/ES: S/N 30001 through 48100
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 |
Old Uno 102: S/N 20001 through 21300 New Uno 102: S/N 30001 through 48100 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 |
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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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