Canon Medical System, USA, INC. has recalled three X-ray systems, including the INFX-8000F and an interventional C-arm system, because a manufacturing change in the internal board can cause abnormal images. These devices may display horizontal stripes during imaging, which can lead to an inability to complete a medical exam or require the patient to be re-examined using a different system. The recall affects 3 units distributed in California and Louisiana.
A defect in the manufacturing of the VAREX internal board causes horizontal stripes to appear on X-ray images, preventing doctors from obtaining clear diagnostic information. This failure can delay critical medical procedures and potentially expose patients to additional radiation if they must undergo a repeat examination on a different system.
Manufacturer Repair or Instruction
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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