FDA-Device2016-07-06Class II
Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric
Pentax Medical Company
Hazard
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Sold states
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Affected count
819 units
Manufactured in
3 Paragon Dr, Montvale, NJ, United States
Products
Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2077-2016Don't want to check this manually?
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