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Recall Observatory FDA recall evidence

Device product

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

Z-2077-2016

April 06, 2016

Class II

Product summary

Firm
Pentax Medical Company
Event
Event 73894
Status
Terminated
Classification
Class II
Quantity
819 units
Official record key
device-enforcement:Z-2077-2016

Official wording

Reason: 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.

Code information: Model #'s EG-3630U, EG-3630UR, EG-3670URK, EG-3830UT, EG-3870UTK, FG-34UX, FG-36UX and FG-38UX

Distribution pattern: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.