FDA-Device2025-08-27Class II
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Pentax of America Inc
Hazard
During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. 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 membrane.
Sold states
US Distribution to states of: AZ, CA, DC, FL IA, ID, IL, KS, MA, MD, MI, MO, NC, NJ, NM, NY, OK, PA, TX, WA.
Affected count
144 units
Manufactured in
3 Paragon Dr, N/A, Montvale, NJ, United States
Products
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2329-2025Don't want to check this manually?
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