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U.S. Department of Health and Human Services

Class 2 Device Recall BariAir

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 Class 2 Device Recall BariAirsee related information
Date Initiated by FirmOctober 21, 1998
Date PostedJanuary 09, 2003
Recall Status1 Terminated 3 on January 28, 2003
Recall NumberZ-0414-03
Recall Event ID 25197
510(K)NumberK955243 
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
ProductKCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
Code Information All serial numbers of beds produced and distributed to the firm''s service centers at the time of correction.
Recalling Firm/
Manufacturer
Kinetic Concepts, Inc
4958 Stout Drive
San Antonio TX 78219
Manufacturer Reason
for Recall
Electrical failure of the bed due to fluid egress into the junction box.
FDA Determined
Cause 2
Other
ActionIn an October 21, 1998 e-mail the firm requested return of the product for a planned upgrade. The junction box cover was corrected at the same time of the upgrade.
Quantity in Commerce144 Beds (6 of which were out of service prior to correction)
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FNL
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