Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1557-2008

Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with...

Arjo, Inc. / initiated 2008-04-10 / Terminated / root cause: design

Arjo, Inc. began a recall of Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); Mast scale is... on . The reason FDA records is "Scale could break and fall potentially causing injuries to someone who is on it. There is a potential for the mast scale load cell ssembly to fracture and allow the mast/boom to fall. Should a patient be in the lift at...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1557-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arjo, Inc.
Product
Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); Mast scale is Intended to be used for weighing patients while in the lifter. Manufactured by Medi-Man Rehabilitation Products Inc., 6200A Tomken Road, Mississauga, Ontario, Canada L5T 1X7, now owned by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
Scale could break and fall potentially causing injuries to someone who is on it. There is a potential for the mast scale load cell ssembly to fracture and allow the mast/boom to fall. Should a patient be in the lift at the time, the patient could fall and sustain injuries.
Root cause tag
design
FDA root cause
Device Design
Action
Arjo sent Urgent Device Recall Customer Notification letters dated 4/1/08 on the BHM Medical letterhead to the end user accounts who received the affected patient lifts with mast scales, advising them of the potential of fracture at the load cell assembly which might cause the scale to fall. Should a patient be in the lift at the time, the patient could fall, potentially sustaining injuries. The accounts were instructed to immediately stop using the patient lifts. A BHM representative will contact the accounts within 5 days to arrange for the correction of the lifts. The accounts will be given the option of returning the lifts for repair (with shipping costs covered by BHM), or purchasing a replacement lift at a significantly reduced price. Any questions or concerns were directed to the BHM Service Department at 1-819-868-0441 or [email protected].
Quantity in commerce
37 lifts
Distribution
Nationwide Distribution --- including states of California, Florida, Illinois, Michigan, Minnesota, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Washington, and Wyoming.
Product codes and lots
Medi-Lifter III Plus, serial numbers 76001/1013, 76003/1015, 76004/1014, 76005/1017, 76027/1019, 76028/1012, 76058/1024, 76128/1034, 76129/1025, 76132/1031, 76133/1039, 76162/1033, 76164/1035, 76221/1069, 76247/1065, 76251/1070, 77091/1079, 77092/1088, 77093/1083, 77126/1084, 77127/1085, 77295/1091, 77342/1096, 77343/1093, 77406/1099, 77407/1098, 77408/1092, 78035/1134, 78036/1132, 78037/1133, 78038/1128, 78039/1103, 78040/1130, 78041/1104;   Summit, serial numbers 4800157/1020, 4800166/1077, 4800173/1086