FDAClass IINovember 23, 2016

SOMATOM Definition AS recall: Software Issue

SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce…

Why was SOMATOM Definition AS recalled?

Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.

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 Number: 8098027 Serial Numbers:96020, 96047,74192,83398,96011,83387 96029

Product
SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
7 systems
Distribution
Nationwide distribution to MI, NY, CA, KY, ND, and NE.
Recall date
November 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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