Pentax Medical Company - Pentax Medical Inc. - Class 2 Recall

EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Product Usage: Intended to provide optical and sonographic visualization via a video monitor of and therapeutic access to the Upper Gastrointestinal Tract. The upper Gastrointestinal Tract include but is not restricted to the organs, tissues, and subsystems: Esophagus, Stomach and Duodenum. These are instruments are introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient population. Intended to provide ultrasonic visualization of and therapeutic access, to the Upper Gastrointestinal Tract. This anatomy i includes, but is not restricted to, the organs, tissues, and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth or the nose as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts