Pentax of America Inc has recalled approximately 384 PENTAX Medical Video Scopes and Processors, including Colonoscopes (EC38-i20cL), Upper GI Scopes (EG29-i20c), and Video Processors (EPK-i8020c). During endoscopic procedures, the device tip can overheat, potentially causing smoke or steam and making the video image appear dark or reddish. This defect can lead to serious internal burns for patients undergoing procedures with these devices.
The light guide at the endoscope tip can become dangerously hot during or after use, which poses a significant risk of thermal injury to a patient's internal mucous membranes. Users have reported seeing smoke-like steam from the devices and observing that the tips are hot to the touch.
Recall number: Z-1236-2025; Quantity: 152 units
Recall number: Z-1237-2025; Quantity: 138 units
Recall number: Z-1238-2025; Quantity: 94 units
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.
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Sources: FDA iRES ยท Raw API Response
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