Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0478-2007

Minstrel Patient Lift with SR weighing scale; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave...

Arjo, Inc. / initiated 2006-08-31 / Terminated

Arjo, Inc. began a recall of Minstrel Patient Lift with SR weighing scale; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model number HMB002-US on . The reason FDA records is "The hanger bar assembly may detach from the lift during use due to fatigue failure of the bolt". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0478-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arjo, Inc.
Product
Minstrel Patient Lift with SR weighing scale; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model number HMB002-US
Product code
FNG Lift, Patient, Ac-Powered
Reason for recall
The hanger bar assembly may detach from the lift during use due to fatigue failure of the bolt.
FDA root cause
Other
Action
Arjo sent an Urgent Device Field Correction Recall letter dated 8/31/06 to all affected end users to the attention of the Administrator/Risk Manager via FedEx on the same date. The letters informed the accounts of the potential for the hanger bar to detach from the scale due to fatigue failure of the pivot bolt. The accounts were advised that an Arjo Field Service Technician would contact them within five business days to schedule a visit to the account to perform an upgrade of their Minstrel lifts. Any questions were directed to Arjo Quality Department at 800-323-1245, ext. 6140.
Quantity in commerce
76 lifts
Distribution
Nationwide
Product codes and lots
Model number HMB002-US, all serial numbers manufactured prior to June 2004. The production date can be determined by the serial number on the mast of the lift. Serial numbers start with MPLA or MPLAT, followed by the last two digits of the year and two digits for the month of production, i.e. MPLA0103 = March 2001.