Recall Z-0970-04 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc.
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)
| Date | Jul 20, 2004 (initiated Apr 30, 2004) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| 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 facilit |
| Quantity | 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, Massachusetts, Ohio, Minnesota, Pennsylvania, Connecticut and Colorado. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.