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U.S. Department of Health and Human Services

Class 2 Device Recall Zuma Mobility System

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  Class 2 Device Recall Zuma Mobility System see related information
Date Initiated by Firm April 06, 2012
Date Posted April 16, 2012
Recall Status1 Terminated 3 on June 19, 2012
Recall Number Z-1431-2012
Recall Event ID 61547
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01.

Product Usage: Human Non-AC-Powered Patient Lift
Code Information Models 412045-01 & 412046-01. Serial Numbers PRNK00001, PRNK00002, PRNK00003, PRNK00004, PRNK00006, PRNK00007, PRJK00001, PRJK00002, PRXK00001, PRXK00002, and PRXK00003.
Recalling Firm/
Manufacturer		 KCI USA, Inc.
4958 Stout Dr
San Antonio TX 78219-4334
For Additional Information Contact Steven Jackson
210-255-6438
Manufacturer Reason
for Recall		 The Zuma Mobility Assist and Trainer have the potential to bind during lowering operation.
FDA Determined
Cause 2		 Device Design
Action KCI sent an Urgent - Voluntary Medical Device Correction notification letters dated April 6, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. KCI will contact affected customers to schedule a time to upgrade the device. For questions contact KCL's Customer Technical Service Center at 1-800-275-4524. Select option 3 followed by option 2.
Quantity in Commerce 4 units
Distribution USA Nationwide Distribution including the states of ID and FL
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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