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Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T recallZ-1175-2026 · Siemens Medical Solutions USA, Inc · initiated Dec 29, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

On December 29, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: Issue 1: Ortho images acquired with preset automatic horizontal flip are not flipped: For ortho examinations, no clinical protocols should be used where the automatic horizontal flip function is active. Issue 2: When acquiring single images, there is the possibility that an image of a previous patient may be processed: a. When acquiring single images with the Dynamic X.fluoro detector, the above-mentioned error message should be observed, and the system should be restarted when it appears. b. Images planned at the Bucky Wall Stand should be acquired on the basic unit or with a mobile detector. Should a single image on the Bucky Wall Stand in horizontal orientation be inevitable, the system must be restarted beforehand. How will the problem be resolved? Siemens Healthineers is preparing a software update to resolve the described problems. The new software version VB10E will be distributed via Update Instruction XP031/25/S during the first quarter of 2026 free of charge. Our service organization will contact you to arrange a date to perform this corrective action. Please feel free to contact our service organization at 1-800-888-7436 for an earlier appointment.

Recall details

Recall number
Z-1175-2026
Status
Open, Classified
Initiated by the company
Dec 29, 2025
Posted by the FDA
Jan 27, 2026
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
7 units
Product code
OWB
FDA submissions
K250660
Distribution
Worldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY, OR, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.

Product description

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K250660 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98244).

Sources and updates

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