Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0606-2009

Liko AB Uno Lifts, Powered (non-AC) Patient Lift: Old Uno 102: S/N 20001 through 21300 New Uno 102 EM/EE/ES...

Liko, Inc. / initiated 2008-11-11 / Terminated / root cause: manufacturing process

Liko North America Inc began a recall of 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... on . The reason FDA records is "Actuator of the lift has the potential to separate when the upper arm is fully extended". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0606-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Liko, Inc.
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.
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
Actuator of the lift has the potential to separate when the upper arm is fully extended.
Root cause tag
manufacturing process
FDA root cause
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.
Product codes and lots
Old Uno 102: S/N 20001 through 21300 New Uno 102: S/N 30001 through 48100 Production Dates: Manufactured prior to June 26, 2008