Z-0414-03
KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic...
KCI USA, Inc. / initiated 1998-10-21 / Terminated
Kinetic Concepts, Inc began a recall of KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas on . The reason FDA records is "Electrical failure of the bed due to fluid egress into the junction box". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0414-03
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- KCI USA, Inc.
- Product
- KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
- Product code
- FNL Bed, Ac-Powered Adjustable Hospital
- Reason for recall
- Electrical failure of the bed due to fluid egress into the junction box.
- FDA 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 in commerce
- 144 Beds (6 of which were out of service prior to correction)
- Distribution
- Nationwide
- Product codes and lots
- All serial numbers of beds produced and distributed to the firm''s service centers at the time of correction.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
