Recall Z-1007-2019 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Olympus Corporation of the Americas
Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
| Date | Dec 17, 2018 |
| Status | Terminated |
| Reason | The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair. |
| Root cause | Under Investigation by firm |
| Action | Customers were contacted via telephone on 12/17/18. Customers were also sent notification letters on 1/2/19. |
| Quantity | 1 |
| Distribution | US Nationwide distribution in the states of CT, IL, MN, MO, and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093395 | OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE Olympus Medical Systems Corporation, Jun 17, 2010 |