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U.S. Department of Health and Human Services

Class 2 Device Recall KinAir MedSurg

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  Class 2 Device Recall KinAir MedSurg see related information
Date Initiated by Firm June 06, 2003
Date Posted March 10, 2005
Recall Status1 Terminated 3 on April 01, 2008
Recall Number Z-0583-05
Recall Event ID 31207
510(K)Number K970468  
Product Classification Bed, Flotation Therapy, Powered - Product Code IOQ
Product KinAir MedSurg, flotation therapy, powered hospital bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
Code Information Serial Numbers KASK00001 through KASK01212
Recalling Firm/
Manufacturer		 Kinetic Concepts, Inc
4958 Stout Dr
San Antonio TX 78219-4334
Manufacturer Reason
for Recall		 Weld failure causes side rail welds to turn upside down or break off of the bed.
FDA Determined
Cause 2		 Other
Action The firm initiated the recall by telephone on 06/06/2003. The firm has inspected and corrected the beds.
Quantity in Commerce 1181 beds
Distribution The beds were distributed nationwide and to Brazil.
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.
510(K) Database 510(K)s with Product Code = IOQ and Original Applicant = KINETIC CONCEPTS, INC.
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