FDAClass IIMarch 20, 2013

Siemens Somatom CTs equipped with software syngo recall

Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.

Why was Siemens Somatom CTs equipped with software syngo recalled?

Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.

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 numbers - 7740769, 8098027, 10430603, and 10590000.

Product
Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
896
Distribution
Nationwide Distribution.
Recall date
March 20, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls