Recall Z-1557-2008 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc.
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, C
| Date | Jul 30, 2008 (initiated Apr 10, 2008) |
| Status | Terminated |
| Reason | 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 | 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 g |
| Quantity | 37 lifts |
| Distribution | Nationwide Distribution --- including states of California, Florida, Illinois, Michigan, Minnesota, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Washington, and Wyoming. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.