FDAClass IINovember 27, 2019

SOMATOM go.Top recall: Software Issue

SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system

Why was SOMATOM go.Top recalled?

SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures

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 syngo CT VA20A_SP2 and active Guide&GO license

Product
SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
14 US
Distribution
US in the states of: GA, IN, MO, MS, NJ, OH, PA
Recall date
November 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls