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U.S. Department of Health and Human Services

Class 2 Device Recall Maxi Move

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  Class 2 Device Recall Maxi Move see related information
Date Initiated by Firm November 05, 2008
Date Posted December 16, 2008
Recall Status1 Terminated 3 on January 05, 2010
Recall Number Z-0503-2009
Recall Event ID 50151
Product Classification Non-AC Powered Patient Lift - Product Code FSA
Product Maxi Move, Model NDA0200-20 Batteries Pack; BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada J1X 5Y5

The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.
Code Information lot number 070826D; This battery pack was solely supplied with Maxi Move floor lift model numbers starting with KMCxxx or sold separately as replacement parts.
Recalling Firm/
Manufacturer		 Arjo, Inc.
50 Gary Ave
Roselle IL 60172-1605
For Additional Information Contact Ms. Traci Giovenco
800-323-1245 Ext. 6125
Manufacturer Reason
for Recall		 The battery pack NDA0200-20, lot 070826D, sold with the Maxi Move patient lift or as replacement parts, has a defective connector that could lead to the inability of the battery pack to recharge and/or short circuit, resulting in smoke emission.
FDA Determined
Cause 2		 Component design/selection
Action Arjo sent the Urgent Device Recall Customer Notification dated 11/5/08 and Field Safety Notice (FSN) dated 10/31/08 to all affected Maxi Move customers on 11/5/08. The accounts were informed of the problem with the connector of the battery pack NDA0200-20, lot 070826D, sold with the Maxi Move patient lift (model numbers starting with KMC)or as replacement parts. They instructed the accounts to discontinue use of the battery pack if it does not recharge or has an intermittent electrical contact. The accounts were requested to complete and return to Arjo Inc., the enclosed customer response form indicating that they have received the notification package. The accounts will be contacted by an Arjo representative within a week to arrange the replacement of the battery pack and corresponding connectors (male part/plug) on the lift and battery charger.
Quantity in Commerce 273 battery packs
Distribution Nationwide Distribution
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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