Olympus Corporation of the Americas Recall 89921
Description: Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Olympus Corporation of the Americas Recall 89921 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1034-2022 |
| Event ID | 89921 |
| Event Description | Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging. |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 731 units |
| Recall Reason | GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients |
| Device Classification | 20220511 |
| Device Code Info | All serial numbers. GTIN: 04953170356322 |
| Center Classification Date | 20220505 |
| Recall Initiation Date | 20220318 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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