Z-2077-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2016
- Initiation Date
- April 6, 2016
- Termination Date
- December 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 819 units
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Code Information
Model #'s EG-3630U, EG-3630UR, EG-3670URK, EG-3830UT, EG-3870UTK, FG-34UX, FG-36UX and FG-38UX