Siemens Medical Solutions USA, Inc: Medical Device Recall in 2026 - (Recall #: Z-1241-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 19, 2025

Date Posted: February 11, 2026

Recall Number: Z-1241-2026

Event ID: 98206

Reason for Recall:

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

Status: Ongoing

Product Quantity: 5 units

Code Information:

Material Number: 11549431; UDI-DI: 04056869978741; Serial Numbers: 183047, 183051, 183048, 183050, 183046;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated