Recall Z-0933-2009 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc.
Ergolift 400 Lbs. Floor Lift, Manufactured by BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada, J1X 5Y5; model/part numbers ERGOLIFT and ERGOLIFT-2 The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.
| Date | Jan 30, 2009 (initiated Dec 8, 2008) |
| Status | Terminated |
| Reason | The manufacturer, BHM Medical, has received reports of structural failure of the mast during use. |
| Root cause | Process control |
| Action | Arjo sent the Urgent Device Recall letter dated 12/22/08 and Field Safety Notice (FSN) dated 12/8/08 to their Ergolift customers on 12/22/08. The accounts were informed of the potential structural failure of the mast on the BHM Medical Ergolift. The letter instructed the accounts to discontinue use of the lifts immediately. Those lifts with serial numbers ERLI-0001 and ERLI-0899 will be taken out of service permanently, and will be replaced with a new device at a significant discount. Those lifts with serial numbers ERLI-0900 and ERLI-1717 will be corrected by a reinforcement kit installed |
| Quantity | 220 lifts |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.