Class IIReported 2026-02-11

NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Recalled by Siemens Medical Solutions USA, Inc

Reason for Recall

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Recall Number

Z-1240-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-19

Reported

2026-02-11

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.

Code Info

Material Number: 11330003; UDI-DI: 04056869263168; Serial Numbers: 127226, 127156, 127268, 127260, 127217, 127313, 127272, 127275, 127276, 127206, 127118, 127152, 127091, 127183, 127166, 127125, 127264, 127220, 127104, 127037, 127136, 127201, 127137, 127221, 127205, 127176, 127297, 127245, 127138, 127314, 127310, 127195, 127259, 127093, 127085, 127215, 127235, 127208, 127256, 127036, 127180, 127242, 127115, 127290, 127146, 127039, 127315, 127203, 127071, 127170, 127318, 127273, 127101, 127046, 127133, 127246, 127083, 127240, 127241, 127299, 127068, 127224, 127139, 127251, 127119, 127265, 127311, 127185, 127111, 127112, 127102, 127249, 127266, 127280, 127132, 127227, 127277, 258044, 127142, 127289, 127075, 127144, 127130, 127131, 127080, 127124, 127271, 127169;

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.