CT software applications recalled because they lack FDA clearance
Siemens is removing three software applications from five NAEOTOM Alpha.Prime CT systems because the applications have not received FDA 510(k) clearance.
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: Scored 2 because the record cites a missing 510(k) clearance rather than a device defect, with no stated consequence or reported harm.
Plain-English summary
The NAEOTOM Alpha.Prime CT system is subject to a recall by Siemens Medical Solutions USA, Inc covering the software applications syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities and syngo.CT ASPECTS.
The reason given in the enforcement record is to remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
The record lists 5 units under material number 11549431, UDI-DI 04056869978741, with serial numbers recorded in the enforcement record. Distribution was worldwide, covering the United States nationwide and Canada, Costa Rica, India and Israel. The FDA has classified the action as Class II.
The record cites a regulatory clearance shortfall rather than a device defect, and reports no injuries. Facilities should follow Siemens' instructions.
The recalled product
- Product
- NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — CT software
- Affected units
- 5
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 (7)
- Material Number: 11549431
- UDI-DI: 04056869978741
- Serial Numbers: 183047
- 183051
- 183048
- 183050
- 183046
Distribution
Distributed nationwide across the United States.
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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