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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 Recall
Minstrel Patient Lift
see related information
Date Posted January 11, 2007
Recall Status1 Terminated on October 16, 2008
Recall Number Z-0478-2007
Recall Event ID 36187
Premarket Notification
510(K) Numbers
K020647  K982650 
Product Classification Lift, Patient, Ac-Powered - 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, Illinois 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
DESIGN: Device Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FNG and Original Applicant = DIDECO S.P.A.
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