FDA Recall
Terminated
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Recall: Z-1465-2022
·
Initiated June 24, 2022
Recall
- Recall Number
- Z-1465-2022
- Event Number
- 90554
- Firm
- Zeiss, Carl Inc
- FEI Number
- 2431026
- Product Code
- MTX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- June 24, 2022
- Terminated
- February 7, 2025
- Address
- 1 Zeiss Dr, Thornwood, NY, 10594-1939
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.
Action
On June 24, 2022, the firm notified their US customer of the recall via email. The customer was informed that a Zeiss service technician will contact them to arrange a date for performing a corrective action to eliminate the risk. The UDI label will be replaced.
Distribution
US Nationwide distribution in the state of NY.
Quantity
1 US; 2 OUS