FDAClass IIJune 3, 2015

SOMATOM Emotion 6 recall: Software Issue

SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray…

Why was SOMATOM Emotion 6 recalled?

Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.

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?

SOMATOM Emotion 6 (2007) - 10165888 with serial numbers: 29338 27232 27230 27231

Product
SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
75
Distribution
Nationwide Distribution including Puerto Rico.
Recall date
June 3, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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