BEUDAMED
    FDA Recall Terminated

    Philips Intellivue Patient Monitor Model MP70 (M8007A)

    Recall: Z-2202-2010 · Initiated June 28, 2010

    Recall

    Recall Number
    Z-2202-2010
    Event Number
    56092
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    June 28, 2010
    Posted
    August 10, 2010
    Terminated
    February 15, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips Intellivue Patient Monitor Model MP70 (M8007A)

    Reason

    Additional Instruction for Use for Intellivue MP60/MP70 to prevent monitors from becoming loose and detaching from the mounting arm.

    Action

    Philips issued on 6/28/10 an Urgent Medical Device Correction notification/Field Safety Notice. Included with the Urgent Medical Device Correction notification/Field Safety Notice is an updated instructions for use and service instructions for these monitors that remind users to follow the mounting arm manufacturer's instructions for use when repositioning the monitor and instructing them to perform a periodic check that the monitor is not loose on the arm.

    Distribution

    Worldwide distribution: USA, Canada, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, Bosnia, BRAZIL, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRI, LITHUANIA, LUXEMBOURG, MACAU, MALAYSIA, MAURITIUS, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA & MONTE NEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, United Arab Emirates, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, VIRGIN ISLANDS (BR), and YEMEN.

    Quantity

    82,019 units