FDA recall Z-0475-2023

Product

Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system

Reason for recall

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

Distribution

US Nationwide

Key facts

Status

Ongoing

Initiation date

2022-11-21

Report date

2022-12-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0475-2023