SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Reported: August 31, 2016 Initiated: July 13, 2016 #Z-2624-2016
Product Description
SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Reason for Recall
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 1 unit
- Distribution
- Distributed to: MI, NY, CA, KY, ND, NE
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 1 unit.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2016. Severity: Moderate. Recall number: Z-2624-2016.
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