Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1381-04

Minerva-Combi Patient Lift, model ML-30; this lift comes with interchangable passive and active lifting...

Medibo N.V. / initiated 2004-08-04 / Terminated

Medibo N.V. began a recall of Minerva-Combi Patient Lift, model ML-30; this lift comes with interchangable passive and active lifting units; Manufactured by Medibo-Technics, Hasseltsebaan... on . The reason FDA records is "The hanger bar may detach from the jib yoke, the M8 bolt in the foot pedal assembly may come loose, and some units may have faulty actuator brackets on the mast assembly, resulting in the patient lift becoming unstable...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1381-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medibo N.V.
Product
Minerva-Combi Patient Lift, model ML-30; this lift comes with interchangable passive and active lifting units; Manufactured by Medibo-Technics, Hasseltsebaan 24, 3940 Hechtel-Eksel, Belgium and distributed by MasterCare Patient Equipment, Inc., Hwy 61 West Industrial Park, Columbus, NE 68601
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
The hanger bar may detach from the jib yoke, the M8 bolt in the foot pedal assembly may come loose, and some units may have faulty actuator brackets on the mast assembly, resulting in the patient lift becoming unstable and allowing the patient to fall.
FDA root cause
Other
Action
Customer Advisory Notice (MB/0407/CAN-001) letters dated 8/6/04 were sent by FedEx Ground Service on 8/4/04 to the end users, informing them of the possibility of the hanger bar assembly to detach from the jib due wear of the pivot assembly within the yoke. They were also advised that the bolt in the foot pedal assembly could come loose, rendering the lift unstable, and that some of the lifts may have faulty actuator brackets on the mast assembly which could result in the collapse of the hoist. The users were requested to inspect their lifts or take them out of service pending service by an authorized service engineer. The users were requested to complete customer response form indicating the model numbers and serial numbers of the lifts at the facility, both in use and out of service, and fax the form back to the Minerva Recall Department at 1-888-594-2756 within 5 days. Within two weeks an authorized service engineer will contact each facility to schedule an appointment to service the lifts at Medibo''s expense. Any questions were directed to the Minerva Recall Department, at 1-888-402-6448.
Quantity in commerce
15 units
Distribution
California, Florida, Louisiana, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Oregon and Pennsylvania.
Product codes and lots
Model ML-30: serial numbers MPBC98022M654, MPBC98022M655, MPBC98022M678, MPBC98062M717, MPBC98062M718, MPBC98062M719, MPBC98062M720, MPBC98062M721, MPCV99102M914, MPCV99102M915, MPCV99102M916, MPCV00012M987, MPCV00072M1073, MPCV00082M1095, MPCV00082M1101