Recall Z-2706-2017 ยท FDS Gastroscope And Accessories, Flexible/Rigid
Fujifilm Medical Systems U.S.A., Inc.
Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
| Date | Feb 17, 2017 |
| Status | Terminated |
| Reason | Fujifilm is recalling multiple endoscopes after a retrospective review. |
| Root cause | Other |
| Action | Fujifilm sent an Urgent - Medical Device Removal letter dated February 17, 2017. Customers are provided information regarding the recall and asked to complete the attached form and return to Fujifilm. Questions can be directed to sales representative. For further questions, please call (973) 709-2202. |
| Quantity | 4 units |
| Distribution | US Distribution to : AL, HI and MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063847 | FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 Fujinon, Inc., Mar 1, 2007 |