Siemens SOMATOM Force CT scanners recalled for radiation exposure risk
Siemens is recalling 91 SOMATOM Force CT scanners due to a software issue 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 unnecessary radiation exposure, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 91 units of the SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system. The recall is due to a potential risk of unnecessary radiation exposure caused by a software issue in the CARE Dose4D algorithm.
The affected devices were distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico. The source text notes that the software issue was found in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash, and SOMATOM Force.
The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries resulting from the defect.
The recalled product
- Product
- SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 91
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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