KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic Concepts, Inc., S
FDA device recall Z-0414-03 · posted 2003-01-09 · Terminated
Recall details
- Recalling firm
- Kinetic Concepts, Inc
- Reason for recall
- Electrical failure of the bed due to fluid egress into the junction box.
- Action taken
- 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
- Status
- Terminated
- Product code
- FNL
- Quantity affected
- 144 Beds (6 of which were out of service prior to correction)
- Distribution
- Nationwide
- Date initiated
- 1998-10-21
- Date posted
- 2003-01-09
- Date terminated
- 2003-01-28
- Location
- San Antonio, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARIAIR (K955243) | Kinetic Concepts, Inc. | 1997-10-23 |