Olympus Corporation of the Americas Recall 88981
Description: EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Olympus Corporation of the Americas Recall 88981 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0379-2022 |
| Event ID | 88981 |
| Event Description | EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 14,447 units |
| Recall Reason | Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients. |
| Device Classification | 20211222 |
| Device Code Info | All serial numbers. UDI: 04953170339967 |
| Center Classification Date | 20211210 |
| Recall Initiation Date | 20211102 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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