FDAClass IIAugust 21, 2019

SOMATOM Definition Flash recall: Software Issue

SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images…

Why was SOMATOM Definition Flash recalled?

Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

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?

Serial Numbers: 73008 98642

Product
SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
N/A
Distribution
US Nationwide distribution.
Recall date
August 21, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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