Olympus Corporation of the Americas Recall 90232
Description: EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
Olympus Corporation of the Americas Recall 90232 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1275-2022 |
| Event ID | 90232 |
| Event Description | EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AL, FL, NC, NY. |
| Quantity | 8 units |
| Recall Reason | Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications |
| Device Classification | 20220629 |
| Device Code Info | UDI-DI: 04953170305276 Serial: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773 and 2962545 |
| Center Classification Date | 20220621 |
| Recall Initiation Date | 20220422 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | |
| Similar To |