Canon Medical System, USA, INC. has recalled 605 Alphenix interventional fluoroscopic x-ray systems, including models INFX-8000C, INFX-8000F, INFX-8000H, and INFX-8000V. It was discovered that fixing screws on the ceiling movement gear within the suspended arm can become loose over time. This defect can prevent the system from moving laterally, generate abnormal noises, or trigger sensor errors during medical procedures.
Loose screws in the ceiling suspension system can lead to a loss of lateral movement of the x-ray arm. This mechanical failure could potentially interfere with surgical or interventional procedures by preventing the equipment from being positioned correctly.
Quantity: 172 units. Manufactured in the United States.
Quantity: 98 units. Manufactured in the United States.
Quantity: 3 units. Manufactured in the United States.
Quantity: 332 units. Manufactured in the United States.
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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