Siemens CT Scanners Recalled for Potential Unnecessary Radiation Exposure
Siemens Medical Solutions is recalling 1,385 SOMATOM Definition AS 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 is classified as FDA Class II. The hazard involves potential 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 1,385 units of the SOMATOM Definition AS (Model 8098027) 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 several Siemens Healthineers CT scanner types, including the SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash, and SOMATOM Force.
This recall is classified as FDA Class II. No specific instructions for consumers or healthcare providers are provided in the source text, but the recall is intended to address the software defect to prevent potential overexposure to radiation.
The recalled product
- Product
- SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 1,385
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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