BEUDAMED
    FDA Recall Terminated

    GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.

    Recall: Z-1734-2019 · Initiated May 6, 2019

    Recall

    Recall Number
    Z-1734-2019
    Event Number
    82792
    Firm
    Maquet Cardiovascular Us Sales, Llc
    FEI Number
    3008355164
    Product Code
    LGX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 6, 2019
    Posted
    June 4, 2019
    Terminated
    July 6, 2022
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.

    Reason

    User may suffer an electric shock when coming in contact with the exposed electronic components

    Action

    Maquet /Getinge issued URGENT MEDICAL DEVICE CORRECTION Notice on 5/6/19, identified issued, health risk and action to take: Per the IFU, section 8.1, a visual and functional check is required to be performed by a trained person before operation; If the plastic socket of the cold-device plug is pulled out do not try to put it back into the housing and if there are any exposed electronic components: do not touch them. Call your in-house technical service and arrange the repair of the table. Per IFU section 8.5 a defective product may not be used and may not be repaired by yourself. Complete/sign and return the MEDICAL DEVICE RECALL CORRECTION RESPONSE FORM. Questions contact Technical Support Department at 1-888-627-8383 (press option 3 then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. Expanded Recall: Maquet/Getinge issued letters on 9/24/20 to consignees via FedEx 2 day Delivery with Signature Proof of Delivery (SPOD).

    Distribution

    Worldwide - US Nationwide Distribution Foreign: ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BOLIVIA BOTSWANA BOSNIA AND HERZEGOVINA BRAZIL BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ECUADOR EGYPT FINLAND FRANCE GABON GERMANY GREECE HONG KONG HONDURAS HUNGARY ICELAND INDIA IRAN IRELAND ISRAEL ITALY JAPAN JORDAN KUWAIT LATVIA LEBANON LITHUANIA MACEDONIA MALAYSIA MAURITIUS MEXICO MOLDAVA MONTENEGRO MOROCCO MYANMAR NETHERLANDS NAMIBIA NORWAY NEW ZEALAND PAKISTAN PARAGUAY PERU PHILIPPINES POLAND PORTUGAL ROMANIA SAUDI ARABIA SERBIA SINGAPORE SLOVAKIA SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND SYRIA TAIWAN TANZANIA THAILAND TURKEY TURKMENISTAN UKRAINE UNITED ARAB EMIRATES URUGUAY UNITED KINGDOM VIETNAM

    Quantity

    U.S: 163; Foreign: 1864. Expanded: US:27 Foreign: 455