Siemens SOMATOM Definition AS CT Scanner Software Recall
Siemens Medical Solutions is recalling 113 SOMATOM Definition AS CT scanners to fix a software bug affecting visual warnings and image quality.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes software corrections to improve system behavior and image quality without reporting any specific injuries, illnesses, or deaths.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 113 units of the SOMATOM Definition AS, a medical device intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. The recall is due to software bug issues in software version VA48A_SP0.
The software update resolves several safety issues, including corrections to improve visual warning and error indication on the gantry display, improve acquisition data to optimize image quality, and improve robustness and general system behavior in some exception handling procedures. The affected units were distributed nationwide.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to arrange for the software update. The recall number is Z-0021-2016.
The recalled product
- Product
- SOMATOM Definition AS, intended 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 angles or spiral planes taken at different angles.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 113
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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