Siemens SOMATOM Sensation 16 CT Scanner Recalled for Dose Calculation Errors
Siemens is recalling 1,301 SOMATOM Sensation 16 CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially causing 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 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.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,301 units of the SOMATOM Sensation 16 CT scanner. The device is intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. The recall is due to possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on posterior-anterior or anterior-posterior 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.
Customers should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- SOMATOM Sensation 16 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)
- 7393114
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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