Class 1 Device Recall Minstrel Patient Lift

• Date Initiated by Firm: April 30, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on August 04, 2004
• Recall Number: Z-0970-04
• Recall Event ID: 28958
• Product Classification: Lift, Patient, Non-Ac-Powered - Product Code FSA
• Product: 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)
• Code Information: model numbers HMB001-US and HMB002-US, all units with and without scales up to and including serial number MPLAT0307W855
• FEI Number: 1419652
• Recalling Firm/ Manufacturer: Arjo, Inc.; 50 Gary Ave Ste A; Roselle IL 60172-1684
• For Additional Information Contact: Ms. Brenda Ammonette; 800-323-1245
• Manufacturer 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.
• FDA Determined 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 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.