FDA recall Z-1465-2022

Zeiss, Carl Inc · Class III · device

Product

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

US Nationwide distribution in the state of NY.

Key facts

Status: Terminated
Initiation date: 2022-06-24
Report date: 2022-08-03
Termination date: 2025-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Thornwood, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1465-2022