Siemens Medical Solutions USA recalled five LUMINOS Q.namix T X-ray systems on December 29, 2025. The recall affects devices that can process images from previous patients due to a software issue. Healthcare providers must stop using these devices immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the LUMINOS Q.namix T Interventional Fluoroscopic X-Ray System, Siemens Material Number (SMN): 11574003, with Software Version VB10D-SP02. The recall involves five units distributed worldwide, including states such as AK, IL, NY, VA, and WI.
The issue involves ortho images that are not flipped as intended when acquired, which may lead to processing images from previous patients. This poses significant risks to patient safety and diagnosis.
There have been no reported injuries or deaths associated with this device malfunction at this time. The potential for misdiagnosis exists if incorrect patient images are processed.
Stop using the device immediately. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for further instructions.
For more information, contact Siemens Medical Solutions USA, Inc at 1-800-xxx-xxxx or visit https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1175-2026.
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