GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.
This recall has been terminated (originally issued July 12, 2007).
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- July 6, 2007
- Posted
- July 12, 2007
- Terminated
- February 1, 2013
- Recall Number
- Z-0989-2007
- Quantity
- 22 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.
Distribution
Worldwide, including USA, France, Singapore, Sweden, and Switzerland.
Lot / Code Info
Serial numbers: E2-0083, E2-0096, E2-0100, E2-0122, E2-0139, E2-0141, E2-0144, E2-0153, E2-7040-MH, E2-7054-MH, E2-7062-MH, E2-7070-MH, E9-0012, E9-0029, E9-0059, E9-0085, E9-0106, E9-0114, E9-0170, ES-0052, ES-0159, ES-0171.
Root Cause
Other
Action Taken
Consignees were notified by certified letter on 07/06/2007. They were told that a service rep would contact them to provide a label and an addendum to their operator's manual. A permanent software solution is under development and will be provided when it becomes available.