Z-2279-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2016
- Initiation Date
- April 6, 2016
- Termination Date
- July 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 819 units
Product Description
Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Reason for Recall
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Distribution Pattern
US Nationwide Distribution
Code Information
Model #'s EG-3630U, FG-38UX, EG-3630UR, FG-34UX, FG-36UX, EG-3830UT, EG-3670URK and EG-3870UTK.