Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0520-06

RotoProne powered patient rotation bed, part #209500, distributed by Kinetic Concepts, Inc., San Antonio, TX

KCI USA, Inc. / initiated 2005-01-24 / Terminated / root cause: software

Kinetic Concepts, Inc began a recall of RotoProne powered patient rotation bed, part #209500, distributed by Kinetic Concepts, Inc., San Antonio, TX on . The reason FDA records is "To correct software issues in software versions 1.3 and 1.5 and to upgrade hatch latch handles to a more ergonomic design". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0520-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
KCI USA, Inc.
Product
RotoProne powered patient rotation bed, part #209500, distributed by Kinetic Concepts, Inc., San Antonio, TX.
Product code
IKZ Bed, Patient Rotation, Powered
Reason for recall
To correct software issues in software versions 1.3 and 1.5 and to upgrade hatch latch handles to a more ergonomic design.
Root cause tag
software
FDA root cause
Other
Action
All KCI Service Centers notified via Technical Bulletin of upgrades. 1/24/2005
Quantity in commerce
91
Distribution
Devices distributed nationwide.
Product codes and lots
Serial Numbers: RRFK00036 - RRFK00128.