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U.S. Department of Health and Human Services

Class 2 Device Recall Minstrel Patient Lift

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  Class 2 Device Recall Minstrel Patient Lift see related information
Date Initiated by Firm August 31, 2006
Date Posted January 11, 2007
Recall Status1 Terminated 3 on October 16, 2008
Recall Number Z-0478-2007
Recall Event ID 36187
Product Classification patient lift - Product Code FNG
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
Code Information 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.
Recalling Firm/
Manufacturer		 Arjo, Inc.
50 Gary Ave
Roselle IL 60172-1605
For Additional Information Contact Ms. Traci Giovenco
800-323-1245
Manufacturer Reason
for Recall		 The hanger bar assembly may detach from the lift during use due to fatigue failure of the bolt.
FDA Determined
Cause 2		 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
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.
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