Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB001-US and HMB002-US (with scale)
FDA Recall Z-0970-04 · Posted 2004-07-20
Recalling FirmArjo, Inc.
Recall StatusTerminated
Product CodeFSA
Date Initiated2004-04-30
Date Terminated2004-08-04
Product Quantity112 units
Reason for Recall
The hanger bar may detach from the jib yoke, and the M8 bolt in the foot pedal assembly may come loose, resulting in the patient lift becoming unstable.
Firm Action
Field Correction Notification letters dated 4/30/04 were sent by certified mail to the end users, informing them of the possibility of the hanger bar assembly to detach from the jib due wear of the pivot assembly within the yoke. They were also advised that the bolt in the foot pedal assembly could come loose, rendering the lift unstable. The users were requested to inspect their lifts or take them out of service pending service by an Arjo service engineer. The users were requested to complete customer response form indicating the model numbers and serial numbers of the lifts at the facility, both in use and out of service, and either mail or fax the form back to Arjo. Within two weeks an Arjo service engineer will contact each facility to schedule an appointment to service the lifts at Arjo's expense. Any questions were directed to Don Smith, Technical Service Director, at 1-800-323-1245, ext. 6167.
Root Cause
Other
Distribution Pattern
District of Columbia, New York, Washington, Iowa, Florida, North Carolina, Louisiana, Virginia, Georgia, Maryland, West Virginia, Texas, Tennessee, South Carolina, Kansas, Nebraska, Hawaii, Massachusetts, Ohio, Minnesota, Pennsylvania, Connecticut and Colorado.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.