Class 1 Device Recall Minerva Patient Lift

• Date Initiated by Firm: August 04, 2004
• Date Posted: August 26, 2004
• Recall Status: Terminated on December 13, 2004
• Recall Number: Z-1381-04
• Recall Event ID: 29662
• Product Classification: Lift, Patient, Non-Ac-Powered - Product Code FSA
• Product: Minerva Patient Lift, model ML-20; this lift has a passive lifting unit; 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
• Code Information: Model ML-20: serial numbers 952056, 952057, 952112, 952113, 952114, 952115, 952116, 952117, 962118, 952119, 952120, 952121, 962214, 962215, 962216, 962217, 962218, 962235, 962236, 962238, 962239, 962240, 962241, MPBX 97052M563, MPBX97052M564, MPBX97052M565, MPBX97052M566, MPBX97052M567, MPBX97052M568, MPBX97052M569, MPBX97052M570, MPBX97052M571, MPBX97052M572, MPBX97052M573, MPBX97052M574, MPBX97052M575, MPBX97052M576, MPBX97052M577, MPBX97052M578, MPBX97052M579, MPBX98022M649, MPBX98022M650, MPBX98022M651, MPBX98022M652, MPBX98022M653, MPBX98022M676, MPBX98022M677, MPBV00032M1013, MPBV00072M1074,
• FEI Number: 3004468271
• Recalling Firm/ Manufacturer: Medibo N.V.; Heikant 5; Hanmont, Achel Belgium
• For Additional Information Contact: Ms. Brenda Ammonette; 888-402-6448
• Manufacturer 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 Determined 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: 49 units
• Distribution: California, Florida, Louisiana, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Oregon and Pennsylvania.
• 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.