FDA-Device2025-03-05Class II
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
Pentax of America Inc
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.
Sold states
Nationwide
Affected count
152 units
Manufactured in
3 Paragon Dr, N/A, Montvale, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1236-2025Don't want to check this manually?
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