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Pentax of America Inc recalls PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic a
Recalled March 5, 2025 · FDA recall Z-1236-2025 · Pentax of America
Hazard
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes. · FDA Class II
Units
152 units
Sold at
Nationwide
Description
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
Product
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
Manufacturer(s)
Pentax of America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →