medical Class II Updated 2021-09-22

Pentax of America Inc recalls Gastroscope Family # 1-Gastroscopes without a Water Jet Chan

Recalled Product

Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK

Hazard / Issue

Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All devices distributed by Pentax in the US between April 2014 and May 2021
View official government recall

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