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.
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