GEHC OEC 9800 ESP-15 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-0990-2007
- Quantity
- 4 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: 8S-2329, 8S-3288-H, 8S-7232-MH, 89-3562.
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.
More recalls by Ge Oec Medical Systems, Inc
OEC 3D REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopi...
Dec 18, 2024
OEC 9800 REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed...
Dec 18, 2024
OEC 9900 REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoro...
Dec 18, 2024
OEC Elite REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is i...
Dec 18, 2024
OEC 9800 Systems with 9-inch Image Intensifier
Jul 31, 2023