Siemens Medical Solutions USA recalled 40 units of its LUMINOS Q.namix R X-ray system on December 29, 2025. The recall addresses a defect that may result in images being incorrectly processed, potentially showing images from previous patients. Healthcare providers should stop using the device immediately and follow recall instructions.
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 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R, Siemens Material Number (SMN): 11574002, Software Version VB10D-SP02. The system was distributed widely, including states such as AK, IL, NY, VA, WI, and internationally in countries like Austria, Belgium, and Germany.
The device may not flip ortho images as intended, risking exposure of a patient's image from a previous examination. This malfunction poses a high risk for misdiagnosis or incorrect treatment based on inaccurate imaging.
No specific incidents or injuries have been reported related to this recall. However, the potential for misdiagnosis due to incorrect images remains a significant concern.
Healthcare providers and patients should cease using the device immediately. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for further instructions and follow the provided recall notifications.
For more information, contact Siemens Medical Solutions USA, Inc. at their official website or through the FDA recall page.
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