Olympus Corporation of the Americas Recall 93212
Description: EVIS EXERA III Gastrointestinal Videoscope
Olympus Corporation of the Americas Recall 93212 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0288-2024 |
| Event ID | 93212 |
| Event Description | EVIS EXERA III Gastrointestinal Videoscope |
| Product Type | Devices |
| Distribution | Nationwide Distribution. |
| Quantity | 1687 units |
| Recall Reason | Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel. |
| Device Classification | 20231115 |
| Device Code Info | Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers. |
| Center Classification Date | 20231109 |
| Recall Initiation Date | 20231002 |
| Recalling Firm | Olympus Corporation of the Americas |
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