Siemens SOMATOM Sensation Cardiac CT Scanner Recalled for Dose Calculation Error
Siemens is recalling 1,301 SOMATOM Sensation Cardiac CT scanners because a software algorithm may incorrectly calculate radiation dose 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-harm product (unnecessary radiation exposure) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,301 units of the SOMATOM Sensation Cardiac CT scanner. The device is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. The recall is due to a potential software error in the CARE Dose4D algorithm.
The issue involves incorrect tube current calculations for head scans based on posterior-anterior (p.a.) or anterior-posterior (a.p.) topograms. Depending on the geometrical shape of the skull bone, the calculated dose distribution may be inappropriate in rare cases. This could lead to unnecessary radiation exposure for patients.
The affected units were distributed nationally in the United States. The source text does not specify a date range for the distribution or the specific model years affected. Siemens is informing customers of this issue to address the potential for incorrect dose calculations.
The recalled product
- Product
- SOMATOM Sensation Cardiac 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)
- 7543106
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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