Olympus Corporation of the Americas Recall 88562
Description: BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
Olympus Corporation of the Americas Recall 88562 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2566-2021 |
| Event ID | 88562 |
| Event Description | BF-XP60 OES Bronchofiberscope, Model No. BF-XP60 |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. Product also distributed globally. |
| Quantity | 180 |
| Recall Reason | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." |
| Device Classification | 20211006 |
| Device Code Info | All serial numbers |
| Center Classification Date | 20210924 |
| Recall Initiation Date | 20210816 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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