BEUDAMED
    FDA Enforcement Class II Terminated

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP

    Recall: Z-1855-2019 · Reported July 3, 2019

    Enforcement

    Recall Number
    Z-1855-2019
    Event ID
    82978
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular Us Sales, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2019
    Initiation Date
    May 28, 2019
    Classification Date
    June 21, 2019
    Termination Date
    July 10, 2023
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP

    Reason

    Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection

    Code Info

    Serial Numbers: 25004 25005 25006 25007 28003 28004 31000 31001 31002 31003 31004 31005 31006 31008 31009 31011 31012 31013 31014 31015 31016 31017 31019 31020 31030 31039 31040 31041 31042 31043 31044 31045 31046 31047 31048 31050 31051 31052 31053 31054 31055 31056 38025 38026 38027 38028

    Distribution

    Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND

    Quantity

    46 units