syngo.CT software version VA48A_SP5.5 in the following recall: Software Issue
syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition…
Why was syngo.CT software version VA48A_SP5.5 in the following recalled?
SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans
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?
syngo.CT software version VA48A_SP5.5
- Product
- syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 2867 units worldwide (OUS); 1464 units US
- Distribution
- Nationwide Foreign:
- Recall date
- September 11, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)