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
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