Recall Z-1174-2026— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1174-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-29

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2025-12-29. It names one FDA 510(k) clearance: K250660. Product: Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02. Reason: Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-12-29
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K250660 — LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions·cleared 2025-07-14

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

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02

Reason for recall

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.

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