Siemens SOMATOM Spirit CT Scanner Recalled for Incorrect Dose Calculations
Siemens Medical Solutions is recalling SOMATOM Spirit CT scanners because the CARE Dose4D algorithm may calculate incorrect tube current for head scans, potentially leading to unnecessary radiation 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 involves a risk of unnecessary radiation exposure, which is a risk-of-harm product 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 Spirit CT scanner. These devices are intended to produce cross-section images of the body by computer reconstruction of x-ray transmission data. The recall is due to a potential software issue in the CARE Dose4D algorithm.
The issue involves possible incorrect tube current calculations 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 USA. Customers should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- SOMATOM Spirit 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
- 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)
- (Not supplied)
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.
See all 15 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · radiation exposure
See all →- HighPhilips Ingenuity CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
- HighPhilips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
- HighPhilips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
FDA (Devices) · 2026-08-05
- HighPhilips Allura Xper hand switch buttons may not fully release
FDA (Devices) · 2026-06-24
- HighPhilips MultiDiagnost Eleva hand switch buttons may not fully release
FDA (Devices) · 2026-06-24