Pentax of America Inc. has recalled approximately 144 units of the Pentax Medical Video Processor, Model EPK-i8020c. During endoscopic procedures, the light guide at the tip of the endoscope can become extremely hot, and users have reported seeing smoke-like steam or the display image turning reddish or dark. This defect can lead to thermal injuries to a patient's internal tissues or mucous membranes. If you are using this specific processor model, contact the manufacturer or your distributor immediately to arrange for corrective action.
The tip of the endoscope can overheat during use or immediately after removal from the patient, posing a significant risk of internal burns or thermal injury to the patient's mucous membranes. Discolored or dark images may also compromise the safety and effectiveness of the medical procedure.
Units used in combination with i20c series video endoscopes.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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