Recall Z-1489-2012 ยท ITX Transducer, Ultrasonic, Diagnostic
Pentax Medical Company
EG-3870UTK, Pentax Ultrasound Video Gastroscope. The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization via a video monitor of, ultrasonic visualization of, and therapeutic access to the Upper Gastrointestinal Tract, including, but restricted to the organs, tissues, and sub-systems; Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument
| Date | May 3, 2012 (initiated Mar 14, 2012) |
| Status | Terminated |
| Reason | Endoscope ultrasound balloon evacuation tube may become clogged with patient body fluid if users fail to properly follow instructions for pre-procedure check, operating the suction valve during procedure and pre-cleaning procedure. |
| Root cause | Equipment maintenance |
| Action | Pentax sent an "URGENT MEDICAL DEVICE RECALL" letter on March 14, 2012 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. A response form was included for customers to complete and return to the firm. Contact the firm at 800-431-5880 ext. 2064 for questions regarding this notice. |
| Quantity | 194 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090197 | EG-3870UTK Pentax Medical Company, May 19, 2009 |