FDAClass IIAugust 8, 2018

SOMATOM Spirit(Model 10045692 ) recall: Software Issue

SOMATOM Spirit(Model 10045692 )

Why was SOMATOM Spirit(Model 10045692 ) recalled?

A potential risk of unnecessary radiation exposure due to a software issue

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 No. 31621 31245 79670 31092 31313 31611

Product
SOMATOM Spirit(Model 10045692 )
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
N/A
Distribution
Nationwide
Recall date
August 8, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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