The Recall Desk
HighFDA (Devices)·Z-2472-2018·Announced 2018-08-08

Siemens SOMATOM Emotion 6 CT Scanner Recalled for Radiation Risk

Siemens Medical Solutions is recalling SOMATOM Emotion 6 CT scanners due to a software issue that may cause unnecessary radiation exposure.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of harm (unnecessary radiation exposure) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the SOMATOM Emotion 6 (Model 10165888) CT scanner. The recall is due to a software issue that presents a potential risk of unnecessary radiation exposure to patients.

The affected units were distributed nationwide. The source text does not specify the number of units affected or report any illnesses or injuries resulting from the defect.

Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software issue and ensure patient safety.

The recalled product

Product
SOMATOM Emotion 6 (Model 10165888)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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