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Recall Observatory FDA recall evidence

Device product

ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000

Z-1465-2022

June 24, 2022

Class III

Product summary

Firm
Zeiss, Carl Inc
Event
Event 90554
Status
Terminated
Classification
Class III
Quantity
1 US; 2 OUS
Official record key
device-enforcement:Z-1465-2022

Official wording

Reason: An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.

Code information: UDI-DI: 4064897000075 Serial Number: 3859001079

Distribution pattern: US Nationwide distribution in the state of NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.