Recall Z-2279-2016 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Pentax Medical Company
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
| Date | Jul 23, 2016 (initiated Apr 6, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Pentax Medical sent an "Urgent Field Correction Letter and Response Form" dated April 6, 2016 via Certified Mail to their affected customers. The recall letter identified the product, problem and action to be taken by customer. The customer is asked to complete the response form even if the customers does not have any OS-H2/OS-H4 water bottles to discard. If customer needs assistance in completing the response form, they can contact their local sales representative. For questions regarding the recall, customers can contact Mr. Paul Silva, Pentax Americas Recall Coordinator at: (800) 431-5880 e |
| Quantity | 819 units |
| Distribution | US Nationwide Distribution |
| 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 |