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U.S. Department of Health and Human Services

Class 2 Device Recall KCI

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  Class 2 Device Recall KCI see related information
Date Initiated by Firm March 22, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 02, 2005
Recall Number Z-0890-04
Recall Event ID 28683
Product Classification Bed, Flotation Therapy, Powered - Product Code IOQ
Product KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX. Model number 201189
Code Information Serial numbers: IVAK00004, IVAK00023, IVAK00028, IVAK00034, IVAK00033, IVAK00032, IVAK00055, IVAK00060, IVAK00062, IVAK00063, IVAK00030, IVAK50000, IVAK00030, IVAK00035, IVAK00027, IVAK00054, IVAK00037, IVAK00041, IVAK00049, IVAK00044, IVAK00045, IVAK00046, IVAK00047, IVAK00048, IVAK00038, IVAK00039, IVAK00042, IVAK00043, IVAK00051, 000038251, 000038253, 000038295, 000038299
Recalling Firm/
Manufacturer		 Kinetic Concepts, Inc
4958 Stout Dr
San Antonio TX 78219-4334
Manufacturer Reason
for Recall		 Battery outgassing of powered hospital beds
FDA Determined
Cause 2		 Other
Action The firm initiated the recall via letter on 03/22/2004.
Quantity in Commerce 33 units
Distribution Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC, IL, OH, MN, AZ, NE, HI, PR, NC
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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