Z-1465-2022 Class III Terminated
FDA device recall Z-1465-2022 was initiated by Zeiss, Carl Inc on June 24, 2022 and is designated Class III. Reason for recall: An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes. The recall status is terminated (terminated February 7, 2025). Affected quantity: 1 US; 2 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2022
- Initiation Date
- June 24, 2022
- Termination Date
- February 7, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 US; 2 OUS
Product Description
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Reason for Recall
An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
Distribution Pattern
US Nationwide distribution in the state of NY.
Code Information
UDI-DI: 4064897000075 Serial Number: 3859001079