FDA Enforcement
Class II
Terminated
SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Recall: Z-2626-2016
·
Reported August 31, 2016
Enforcement
- Recall Number
- Z-2626-2016
- Event ID
- 74840
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 31, 2016
- Initiation Date
- July 13, 2016
- Classification Date
- August 23, 2016
- Termination Date
- January 24, 2017
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418, United States
Description
SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Reason
Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
Code Info
Model # 8098027 Serial # 96020, 96047, 96011, and 96029
Distribution
Distributed to: MI, NY, CA, KY, ND, NE
Quantity
4 systems