Siemens Medical Solutions USA, Inc recalls NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Read the official notice →- Date
- 2026-02-11
- Country
- United States
- Brand
- Siemens Medical Solutions
- Product
- NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Canada, Costa…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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