Siemens SOMATOM Emotion 6 CT Scanner Recalled for Dose Calculation Error
Siemens is recalling 1,301 SOMATOM Emotion 6 CT scanners because the CARE Dose4D algorithm may incorrectly calculate radiation dose for head scans, potentially leading to unnecessary 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 is classified as FDA Class II and involves a risk of unnecessary radiation exposure, which fits the rubric for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,301 units of the SOMATOM Emotion 6 CT scanner. The device is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. The recall was initiated to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm specifically for head scans based on posterior-anterior (p.a.) or anterior-posterior (a.p.) topograms.
The FDA has classified this as a Class II recall. The source text states that depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate. This error could lead to unnecessary radiation exposure for patients undergoing head scans. The affected units were distributed nationally in the USA.
Customers should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the correction of the algorithm. The recall number is Z-1445-2018.
The recalled product
- Product
- SOMATOM Emotion 6 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)
- 10046766
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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