Recall Z-1239-2026— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1239-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-19

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2025-12-19. It names one FDA 510(k) clearance: K233650. Product: SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS. Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-12-19
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K233650 — SOMATOM go.Up +7 moreSiemens Medical Solutions USA, Inc.·cleared 2024-03-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.