Recall Z-2077-2016 ยท ITX Transducer, Ultrasonic, Diagnostic
Pentax Medical Company
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
| Date | Jun 28, 2016 (initiated Apr 6, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Pentax sent an Urgent Field Correction letter dated April 6, 2016 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were reminded to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices passed through the instrument channel are accounted for after use. If the instrument/suction channel does become blocked or clogged due to the accumulation of debris, an accessory that cannot |
| Quantity | 819 units |
| Distribution | Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961974 | FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE Pentax Precision Instrument Corp., Feb 10, 1997 |