FDAClass IIJune 3, 2015

SOMATOM Emotion 16 recall: Software Issue

SOMATOM Emotion 16, 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 16 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 16 (2007) 10165977 with serial numbers: 86514 32490 80553 32552 32530 86406 86558 80542 80461 86405 32512 80441 86431 80467 86425 80442 86429 86557 80434 32581 32637 32597 80448 80431 32624 32469 80446 32578 80430

Product
SOMATOM Emotion 16, 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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