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U.S. Department of Health and Human Services

Class 2 Device Recall Ergolift and Ergolift2 Floor LIfts

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 Class 2 Recall
Ergolift and Ergolift2 Floor LIfts
see related information
Date Posted January 30, 2009
Recall Status1 Open
Recall Number Z-0933-2009
Recall Event ID 50756
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
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.
Code Information serial numbers ERLI-0001 through ERLI-1717, manufactured between 1995 and 1999
Recalling Firm/
Manufacturer
Arjo, Inc.
50 Gary Ave
Roselle, Illinois 60172-1605
For Additional Information Contact Ms. Traci Giovenco
630-307-2756
Manufacturer Reason
for Recall
The manufacturer, BHM Medical, has received reports of structural failure of the mast during use.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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