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Terminated

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

FDA Recall Z-1465-2022 · Posted None

Recalling FirmZeiss, Carl Inc
Recall StatusTerminated
Product CodeMTX
Date Initiated2022-06-24
Date Terminated2025-02-07
Product Quantity1 US; 2 OUS

Reason for Recall

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

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the state of NY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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