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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 September 09, 2010
Date Posted December 13, 2010
Recall Status1 Terminated 3 on March 21, 2011
Recall Number Z-0611-2011
Recall Event ID 56849
Product Classification Bed, patient rotation, powered - Product Code IKZ
Product RotoProne Therapy System, Model 209500, Device List Number E232632
Product is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It is intended for the treatment and prevention of pulmonary complications associated with immobility.
Code Information Serial number ranges: RRFK00036-RRFK00047; RRFK00049-RRFK00115; RRFK00117-RRFK00128; RRFK00141-RRFK00211; RRFK00213-RRFK00233; RRFK00235; RRFK00237-RRFK00254; RRFK00256-RRFK00270; RRFK00273-RRFK00280; RRFK00282-RRFK00284; RRFK00287-RRFK00290; RRJK0001; RRIK00003; RRIK00004; RRFK00234; RRFK00236; RRFK00285; RRFK00286; and RRJK00002
Recalling Firm/
Manufacturer		 KCI USA, Inc.
4958 Stout Dr
San Antonio TX 78219-4334
For Additional Information Contact
210-255-5571
Manufacturer Reason
for Recall		 Product complaints indicating that while attempting to resolve an alarm or error condition, operator was unable to return product to the prone position for patient.
FDA Determined
Cause 2		 Other
Action KCI USA, Inc. sent an URGENT - Medical Device Safety Alert letter, dated September 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the cusotmer. Customers were instructed to have a practiced back-up plan, such as a plan for the manual proning of patients in the event that clinical circumstances dictate the need for more immediate prone therapy. For questions, customers in the US should call KCI's Technical Support Center at 1-800-275-4524, option 5. For customers outside the US they should contact their local sales representative. Customers should contact their accounts with affected product and advise them of the safety notice.
Quantity in Commerce 240 units
Distribution Worldwide Distribution - USA Nationwide, United Kingdom, Germany, and Saudi Arabia
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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