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U.S. Department of Health and Human Services

Class 2 Device Recall RotoRest Delta Kinetic Therapy System

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 Class 2 Recall
RotoRest Delta Kinetic Therapy System
see related information
Date Posted November 20, 2012
Recall Status1 Terminated on April 22, 2013
Recall Number Z-0409-2013
Recall Event ID 62805
Product Classification Bed, Flotation Therapy, Powered - Product Code IOQ
Product RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
Code Information Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.
Recalling Firm/
Manufacturer
KCI USA, Inc.
4958 Stout Dr
San Antonio, Texas 78219-4334
For Additional Information Contact KCI's Customer Technical Service Center
800-275-4524
Manufacturer Reason
for Recall
The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action KCI sent an Urgent - Voluntary Medical Device Correction letter dated June 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that KCI would contact them soon to coorinate a shipment of a replacement of the affected product. For any questions customers were instructed to call 1-800-275-4524, Selection Option 3 followed by Option 2. For questions regarding this recall call 1-800-275-4524.
Quantity in Commerce 282 units
Distribution Nationwide Distribution including AL, CA, CO, OK and GA.
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.
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