Siemens Medical Solutions USA, Inc: Medical Device Recall in 2026 - (Recall #: Z-1240-2026)

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 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-1240-2026

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: 88 units

Code Information:

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;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated