FDA Enforcement
Class III
Terminated
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Recall: Z-1465-2022
·
Reported August 3, 2022
Enforcement
- Recall Number
- Z-1465-2022
- Event ID
- 90554
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zeiss, Carl Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- August 3, 2022
- Initiation Date
- June 24, 2022
- Classification Date
- July 25, 2022
- Termination Date
- February 7, 2025
- Address
- 1 Zeiss Dr, Thornwood, NY, 10594-1939, United States
Description
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Reason
An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
Code Info
UDI-DI: 4064897000075 Serial Number: 3859001079
Distribution
US Nationwide distribution in the state of NY.
Quantity
1 US; 2 OUS