FDAClass IINovember 16, 2016

SOMATOM Definition AS system recall

SOMATOM Definition AS system, x-ray, tomography, computed

Why was SOMATOM Definition AS system recalled?

Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts.

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: 8098027 10430603

Product
SOMATOM Definition AS system, x-ray, tomography, computed
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
57 systems distributed in USA
Distribution
Nationwide Distribution
Recall date
November 16, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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