FDAClass IIMarch 24, 2021

Software versions syngo.CT VA30A_SP2 or syngo.CT recall: Software Issue

Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM…

Why was Software versions syngo.CT VA30A_SP2 or syngo.CT recalled?

SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. Sporadic software errors during interventional workflows may also result

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?

Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a

Product
Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
190 units US
Distribution
US Nationwide distribution.
Recall date
March 24, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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