Siemens SOMATOM Emotion Duo CT Scanner Recalled for Radiation Dose Errors
Siemens is recalling SOMATOM Emotion Duo CT scanners because a software algorithm may calculate incorrect radiation doses for head scans, potentially exposing patients to unnecessary radiation.
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 unnecessary radiation exposure, which is a risk-of-harm product issue where specific injury reports are not stated in the source text, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,301 units of the SOMATOM Emotion Duo (2003) CT scanner. The recall is due to a potential error in the CARE Dose4D algorithm, which may calculate incorrect tube current for head scans based on posterior-anterior or anterior-posterior topograms.
Depending on the specific geometrical shape of a patient's skull, the algorithm may rarely calculate an inappropriate dose distribution. This error could lead to unnecessary radiation exposure for patients undergoing head scans.
The affected scanners were distributed nationally in the United States. Siemens is the recalling firm. Customers should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the software correction or replacement.
The recalled product
- Product
- SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — CT Scanner
- Affected units
- 1,301
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 3813933
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 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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