FDAClass IIJuly 8, 2015

SOMATOM Emotion 6 recall

SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane…

Why was SOMATOM Emotion 6 recalled?

A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.

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: 10165888 with serial numbers: 29161 29185 29186 29165 29176 29181 29198

Product
SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
40 total
Distribution
Nationwide Distribution.
Recall date
July 8, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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