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Recall Observatory FDA recall evidence

Device product

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

Z-1175-2026

December 29, 2025

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 98244
Status
Ongoing
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-1175-2026

Official wording

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.

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.