Z-2467-2023 Class II Ongoing
FDA device recall Z-2467-2023 was initiated by Olympus Corporation of the Americas on July 27, 2023 and is designated Class II. Reason for recall: Recent reports of patient infection. The recall status is ongoing. Affected quantity: 6,426 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2023
- Initiation Date
- July 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,426 units
Product Description
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Reason for Recall
Recent reports of patient infection.
Distribution Pattern
US Nationwide distribution.
Code Information
Model No. TJF-Q190V; UDI-DI: 04953170405563; All Serial No.