Siemens SOMATOM Force CT Scanner Recalled for Imaging Artifacts
Siemens Medical Solutions is recalling seven SOMATOM Force CT scanners because artifacts were found in acquired imaging.
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 imaging artifacts, which is a risk-of-harm product issue where specific injuries are not reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling seven units of the SOMATOM Force computed tomography (CT) scanner. The recall is due to artifacts being found in the imaging acquired by these devices.
The affected units are distributed in Pennsylvania, Massachusetts, Minnesota, South Carolina, Maryland, and Texas. The specific model number is 10742326, and the affected serial numbers are 75437, 75454, 75464, 75450, 75467, 75475, and 75439.
This recall is classified as Class II by the FDA. The source text does not specify further actions for consumers or healthcare providers beyond the recall notification.
The recalled product
- Product
- SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 7
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 (8)
- Model number: 10742326
- serial numbers 75437
- 75454
- 75464
- 75450
- 75467
- 75475
- 75439.
Distribution
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