FDA Enforcement
Class II
Ongoing
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Recall: Z-2029-2024
·
Reported June 12, 2024
Enforcement
- Recall Number
- Z-2029-2024
- Event ID
- 94638
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 12, 2024
- Initiation Date
- April 18, 2024
- Classification Date
- June 6, 2024
- Address
- 3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States
Description
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Reason
The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
Code Info
Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;
Distribution
US Nationwide distribution in the state of NY.
Quantity
1 unit