Siemens SOMATOM Force CT Systems Recalled for Image Artifacts
Siemens is recalling 37 SOMATOM Force CT systems because a software error in the Neonate Head protocol may cause image artifacts, potentially leading to misdiagnosis.
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 is classified as FDA Class II. The hazard involves a risk of misdiagnosis due to image artifacts, which is a significant risk of harm, but the source text does not report any specific injuries, hospitalizations, or fatalities.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 37 SOMATOM Force Computed Tomography (CT) x-ray systems. These systems are intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
The recall is due to an incorrect parameterization of the reconstruction algorithm used for the pediatric head kernel (Hp38) in the Neonate Head protocol. This error can result in image artifacts that mimic non-existing blood or liquid or fail to depict actual existing blood or liquid. This may lead to misdiagnosis or errors in surgery planning.
The affected units were distributed nationwide in the United States, including in North Carolina, New Hampshire, Illinois, Massachusetts, Washington, Pennsylvania, Maryland, Minnesota, Texas, New York, South Carolina, Ohio, California, Kentucky, Montana, and Iowa. Healthcare facilities should contact Siemens for instructions on correcting the software parameterization.
The recalled product
- Product
- SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 37
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 (20)
- SOMATOM Force Material # 10742326
- serial numbers 75550
- 75526
- 75512
- 75567
- 75536
- 75514
- 75563
- 75510
- 75454
- 75540
- 75571
- 75437
- 75500
- 75527
- 75475
- 75535
- 75481
- 75439
- 75450
Distribution
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