Siemens Medical Solutions USA, Inc. is recalling 48 units of the LUMINOS Q.namix R and T Interventional Fluoroscopic X-Ray Systems due to a software defect. The systems may fail to correctly flip images when the 'automatic horizontal flip' preset is used, and more critically, there is a risk that a previous patient's image could be displayed when acquiring a single image of a new patient. Consumers and healthcare facilities should stop using the affected systems and contact Siemens to arrange for a software correction.
The software error can lead to a clinician viewing the wrong patient's image or a misoriented image, which could result in incorrect diagnoses or surgical procedures on the wrong site or the wrong patient.
Siemens Material Number (SMN): 11574002
Siemens Material Number (SMN): 11574003
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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