BEUDAMED
    FDA Enforcement Class II Ongoing

    Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system

    Recall: Z-0476-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0476-2023
    Event ID
    91200
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Leica Microsystems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2022
    Initiation Date
    November 21, 2022
    Classification Date
    December 9, 2022
    Address
    10 Parkway North blvd ste 300, N/A, deerfield, IL, 60089-6622, United States

    Description

    Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system

    Reason

    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.

    Code Info

    ***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.

    Distribution

    US Nationwide

    Quantity

    38 units