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U.S. Department of Health and Human Services

Class 2 Device Recall RotoProne Therapy System

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  Class 2 Device Recall RotoProne Therapy System see related information
Date Initiated by Firm January 24, 2005
Date Posted February 14, 2006
Recall Status1 Terminated 3 on June 29, 2006
Recall Number Z-0520-06
Recall Event ID 34296
Product Classification Bed, Patient Rotation, Powered - Product Code IKZ
Product RotoProne powered patient rotation bed, part #209500, distributed by Kinetic Concepts, Inc., San Antonio, TX.
Code Information Serial Numbers: RRFK00036 - RRFK00128.
Recalling Firm/
Manufacturer		 Kinetic Concepts, Inc
4958 Stout Dr
San Antonio TX 78219-4334
Manufacturer Reason
for Recall		 To correct software issues in software versions 1.3 and 1.5 and to upgrade hatch latch handles to a more ergonomic design.
FDA Determined
Cause 2		 Other
Action All KCI Service Centers notified via Technical Bulletin of upgrades. 1/24/2005
Quantity in Commerce 91
Distribution Devices distributed 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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