Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0933-2009

Ergolift 400 Lbs. Floor Lift, Manufactured by BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada, J1X 5Y5...

Arjo, Inc. / initiated 2008-12-08 / Terminated / root cause: manufacturing process

Arjo, Inc. began a recall of 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... on . The reason FDA records is "The manufacturer, BHM Medical, has received reports of structural failure of the mast during use". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0933-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arjo, Inc.
Product
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.
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
The manufacturer, BHM Medical, has received reports of structural failure of the mast during use.
Root cause tag
manufacturing process
FDA 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 by a qualified technician. The accounts were requested to complete and return to Arjo Inc. within 10 days the enclosed customer response form indicating that they have received the notification, indicating the serial numbers on hand needing correction, and whether they need any replacement lifts. The accounts will be contacted by an Arjo technician within weeks to arrange for the correction of the lifts and/or an Arjo representative for the replacement lifts.
Quantity in commerce
220 lifts
Distribution
Nationwide Distribution.
Product codes and lots
serial numbers ERLI-0001 through ERLI-1717, manufactured between 1995 and 1999