FDA Enforcement
Class II
Ongoing
EVIS EXERA III Gastrointestinal Videoscope
Recall: Z-0288-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0288-2024
- Event ID
- 93212
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- November 15, 2023
- Initiation Date
- October 2, 2023
- Classification Date
- November 9, 2023
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States
Description
EVIS EXERA III Gastrointestinal Videoscope
Reason
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Code Info
Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.
Distribution
Nationwide Distribution.
Quantity
1687 units