FDA Recall Terminated

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)

Recall: Z-0970-04 · Initiated April 30, 2004

Recall

Recall Number
Z-0970-04
Event Number
28958
Firm
Arjo, Inc.
FEI Number
1419652
Product Code
FSA
Status
Terminated
Root Cause
Other
Initiated
April 30, 2004
Posted
July 20, 2004
Terminated
August 4, 2004
Address
50 Gary Ave, Ste A, Roselle, IL, 60172-1684

Description

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)

Reason

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

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.

Distribution

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.

Quantity

112 units