Siemens SOMATOM Emotion 16 CT Scanner Recalled for Radiation Risk
Siemens Medical Solutions is recalling SOMATOM Emotion 16 CT scanners due to a software issue that may cause unnecessary radiation exposure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 16 (10165977) CT scanners. The recall is being conducted because of a software issue that presents a potential risk of unnecessary radiation exposure to patients.
The affected units are distributed nationwide. The recall covers specific serial numbers listed in the official FDA record. The source text does not specify the number of affected units or report any illnesses or injuries.
Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- SOMATOM Emotion 16 (10165977)
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — CT Scanner
- Hazard
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.
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