KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
FDA Recall Z-0414-03 · Posted 2003-01-09
Advertisement
Recalling FirmKinetic Concepts, Inc
Recall StatusTerminated
Product CodeFNL
Date Initiated1998-10-21
Date Terminated2003-01-28
Product Quantity144 Beds (6 of which were out of service prior to correction)
Reason for Recall
Electrical failure of the bed due to fluid egress into the junction box.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement