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Moderate riskFDA DeviceClass II

Siemens LUMINOS Q.namix R X-ray system recalled for image display and patient data mix-up risk

Certain Siemens interventional X-ray systems with software version VB10D-SP02 have a software issue that can cause images to display incorrectly. When the automatic image-flip feature is used, images may not flip as expected, and in some cases, a previous patient's image could appear instead of the current patient's image.

From the FDA notice · Read the official notice ↗ · All Siemens recalls

What to do

  1. If you operate or maintain a LUMINOS Q.namix R system (SMN 11574002), contact Siemens Medical Solutions USA immediately for guidance.
  2. Do not rely on the automatic horizontal flip feature until Siemens provides a software update or fix.
  3. Verify patient images manually before clinical use to ensure correct patient data is displayed.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 2 products — see all of them.

Details

Units affected
41 units
Illnesses reported
None reported
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Classification
Class II
Recall number
Z-1174-2026

In the FDA's words

Description
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02 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. Siemens Material Number (SMN): 11574002; UDI-DI: 04056869993973; Serial Numbers: 150050, 150035, 150033, 150034, 150048, 150021, 150020, 150053, 150023, 150044, 150049, 150037, 150054, 150011, 150059, 150024, 150038, 150051, 150029, 150045, 150032, 150056, 150043, 150055, 150041, 150026, 150025, 150022, 150031, 150039, 150046, 150042, 150028, 150047, 150030, 150052, 150027, 150057, 150040, 150058, 150063; 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. Affected quantity: 41 units
Hazard
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.

2 products in this recall

The agency lists each product separately. Check every one you might have.

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