Siemens CT Scanners Recalled for Potential Unnecessary Radiation Exposure
Siemens is recalling 238 SOMATOM Definition Flash CT scanners due to a software issue in the CARE Dose4D algorithm that may cause 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-harm product (unnecessary radiation exposure) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 238 units of the SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system. The recall is due to a software issue found in the CARE Dose4D algorithm implemented in specific Siemens Healthineers CT scanners, including the SOMATOM Definition Flash.
The affected devices were distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico. The software issue presents a potential risk of unnecessary radiation exposure to patients. The recall covers specific serial numbers listed in the official FDA documentation.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software issue. Patients who have had scans on these devices should consult their healthcare provider if they have concerns about their radiation exposure.
The recalled product
- Product
- SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 238
Distribution
Part of a larger recall action
This product is one of 4 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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