Siemens SOMATOM Sensation 10 CT Scanner Recalled for Dose Calculation Error
Siemens Medical Solutions is recalling 1,301 SOMATOM Sensation 10 CT scanners due to a software error that may cause unnecessary radiation exposure during head scans.
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 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,301 units of the SOMATOM Sensation 10 computed tomography (CT) scanner. These devices are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. The recall is due to a potential error in the CARE Dose4D algorithm used for head scans based on posterior-anterior or anterior-posterior topograms.
In rare cases, depending on the geometrical shape of the skull bone, the algorithm may calculate an inappropriate dose distribution. This error could lead to unnecessary radiation exposure for patients. The affected units were distributed nationally in the United States.
Customers should contact Siemens Medical Solutions USA, Inc. for further information regarding the recall and necessary corrective actions.
The recalled product
- Product
- SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- 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)
- 7543015
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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