Date Initiated by Firm | October 21, 1998 |
Date Posted | January 09, 2003 |
Recall Status1 |
Terminated 3 on January 28, 2003 |
Recall Number | Z-0414-03 |
Recall Event ID |
25197 |
510(K)Number | K955243 |
Product Classification |
Bed, Ac-Powered Adjustable Hospital - Product Code FNL
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Product | KCI 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 |
Action | In 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 Commerce | 144 Beds (6 of which were out of service prior to correction) |
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = FNL
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