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

FDA device recall Z-0933-2009 · posted 2009-01-30 · Terminated

Recall details

Recalling firm

Arjo, Inc.

Reason for recall

The manufacturer, BHM Medical, has received reports of structural failure of the mast during use.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

FSA

Quantity affected

220 lifts

Distribution

Nationwide Distribution.

Date initiated

2008-12-08

Date posted

2009-01-30

Date terminated

2011-01-21

Location

Roselle, IL