SOMATOM Definition Flash with software version recall: Software Issue
SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
Why was SOMATOM Definition Flash with software version 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model # 10590000 Serial # 83398, and 83387
- Product
- SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 2 systems
- Distribution
- Distributed to: MI, NY, CA, KY, ND, NE
- Recall date
- August 31, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)