Siemens CT Scanner Recall Due to Contrast Injection Failure
Siemens is recalling one SOMATOM Definition AS CT scanner because a software error prevents the automatic injection of contrast agent during scans.
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. The hazard is a failure to achieve the desired examination result due to a software error, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling one unit of the SOMATOM Definition AS computed tomography (CT) x-ray system, Model # 10430603, Serial # 74192. The affected unit is equipped with software version VA48A-SP2.
The recall is due to an internal communication error between the device's firmware and software. This error causes the CT scan to execute properly, but the automatic injector is not started. As a result, the contrast agent is not injected, and the desired examination result is not achieved. The issue affects only the automatic or coupled modes of the injector and does not affect manual control.
The affected unit was distributed to facilities in Michigan, New York, California, Kentucky, North Dakota, and Nebraska. Healthcare providers should contact Siemens Medical Solutions USA, Inc. for further instructions on resolving the software error.
The recalled product
- Product
- SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 1
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 (1)
- Model # 10430603 Serial # 74192
Distribution
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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