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FDA Device recall Z-1175-2026

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T

On 2026-02-04 the FDA classified a Class II recall of Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T by Siemens Medical Solutions Usa, citing 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 p….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1175-2026
ClassificationClass II
Statusongoing
Initiated2025-12-29
Published2026-02-04
Last updated2026-09-13 11:58 UTC
CompanySiemens Medical Solutions Usa
DistributionUS

Product

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; 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.

Identifiers

code_infoSiemens Material Number (SMN): 11574003; UDI-DI: 04056869993980; Serial Numbers: 170013, 170022, 170023, 170021, 170020, 170025, 170026;

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1175-2026%22

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