Recall Z-1381-04 ยท FSA Lift, Patient, Non-Ac-Powered
Medibo N.V.
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
| Date | Aug 26, 2004 (initiated Aug 4, 2004) |
| Status | Terminated |
| Reason | 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. |
| 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 au |
| Quantity | 15 units |
| Distribution | California, Florida, Louisiana, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Oregon and Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.