Agency classClass IIOur severity:High FDA (Devices)·Z-1175-2026·Announced 2026-02-04

Q.namix T fluoroscopy systems recalled over unflipped and mismatched images

Siemens is recalling 7 units of the LUMINOS Q.namix T fluoroscopic X-ray system because ortho images may not be flipped as preset and an image of a previous patient may be processed.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states images may not be flipped as preset and a previous patient's image may be processed, and no injuries are reported.

Plain-English summary

The interventional fluoroscopic X-ray system LUMINOS Q.namix T, Siemens Material Number 11574003, with software version VB10D-SP02, is being recalled by Siemens Medical Solutions USA, Inc.

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

The record lists 7 units under UDI-DI 04056869993980, with serial numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across Alaska, California, Illinois, Minnesota, New York, Oregon, Virginia and Wisconsin, and other countries listed in the record. The FDA has classified the action as Class II.

An unflipped image or an image belonging to a previous patient is content a clinician reads. The enforcement record reports no injuries. Facilities should follow Siemens' instructions.

The recalled product

Product: Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Fluoroscopy
Hazard: image-orientation
wrong-patient-image
software-fault
fluoroscopy
Affected units: 7

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

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

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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