FDA Medical Device Recalls (openFDA)
Kinetic Concepts, Inc: KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
- Recall number
- Z-0414-03
- Recalling firm
- Kinetic Concepts, Inc
- Product
- KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
- Status
- Terminated
- Initiated
- 1998-10-21
- Posted
- 2003-01-09
- Terminated
- 2003-01-28
- Reason
- Electrical failure of the bed due to fluid egress into the junction box.
- Root cause
- 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
- 144 Beds (6 of which were out of service prior to correction)
- Distribution
- Nationwide
- Lot, serial or model codes
- All serial numbers of beds produced and distributed to the firm''s service centers at the time of correction.
- 510(k) numbers
- ["K955243"]
- PMA numbers
- not on file
- Product code
- FNL
- Firm FEI
- 1625774
- Firm city
- San Antonio
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28