Z-0476-2023 Class II Ongoing

Recalled by Leica Microsystems, Inc. — deerfield, IL

Recall Details

Product Type
Devices
Report Date
December 21, 2022
Initiation Date
November 21, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
38 units

Product Description

Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). 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 Pattern

US Nationwide

Code Information

***EXPANSION 09/08/2023 UPDATE a. Premium Part Number 10448950; Serial Numbers: 160222001, 280622001, 50422001, 50422002, 91221001, 180622001, 170622001, 61221001, 130922001, 120623001, 150623001, 81022001, 200623001, 51022001, 61022001. b. Standard Part Number 10448976; Serial Numbers: 120322001, 300122001, 40222002, 301221001, 40122001, 140522001, 151221002, 81221002, 100222002, 300122002, 110322001, 50322001, 90622001, 120422001, 90522001, 100522001, 250122001, 100222001, 171022001, 80922001, 70623001, 30922001, 91022001.