FDAFDA · Food and drugs·Recall number Z-2624-2016
SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Published August 31, 2016 · Recall initiated: July 13, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Distributed to: MI, NY, CA, KY, ND, NE
- Lot
- Model # 10430603 Serial # 74192
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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