FDA-Device2021-09-22Class II
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK
Pentax of America Inc
Hazard
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
Sold states
Nationwide
Affected count
28849 units Total
Manufactured in
3 Paragon Dr, N/A, Montvale, NJ, United States
Products
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2448-2021Don't want to check this manually?
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