Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB0

FDA device recall Z-0970-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Arjo, Inc.

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.

Action taken

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

Status

Terminated

Product code

FSA

Quantity affected

112 units

Distribution

District of Columbia, New York, Washington, Iowa, Florida, North Carolina, Louisiana, Virginia, Georgia, Maryland, West Virginia, Texas, Tennessee, South Carolina, Kansas, Nebraska, Hawaii, Massachuse

Date initiated

2004-04-30

Date posted

2004-07-20

Date terminated

2004-08-04

Location

Roselle, IL