Aizu Olympus Co., Ltd. Recall 93335
Description: PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Aizu Olympus Co., Ltd. Recall 93335 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0419-2024 |
| Event ID | 93335 |
| Event Description | PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE |
| Product Type | Devices |
| Distribution | Domestic distribution to FL, KY, MA, NJ, NY, and PA |
| Quantity | 24 incorrectly repaired units |
| Recall Reason | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection. |
| Device Classification | 20231206 |
| Device Code Info | UDI-DI 04953170305191 Serial Numbers 2302719, 2516751 |
| Center Classification Date | 20231129 |
| Recall Initiation Date | 20231016 |
| Recalling Firm | Aizu Olympus Co., Ltd. |
| Initial Notification | Letter |
| Similar To |