BEUDAMED
    FDA Enforcement Class II Terminated

    Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.

    Recall: Z-0563-2021 · Reported December 16, 2020

    Enforcement

    Recall Number
    Z-0563-2021
    Event ID
    86753
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spacelabs Healthcare, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 16, 2020
    Initiation Date
    November 6, 2020
    Classification Date
    December 10, 2020
    Termination Date
    October 18, 2024
    Address
    Unit B, Foxholes Centre; John Tate Road, Hertford, N/A, N/A, United Kingdom

    Description

    Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.

    Reason

    During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time of the upgrade, may have unrelated comments added. Existing comments will not be overwritten or removed. Rhythm ECG Tests may have comments overwritten with unrelated comments. Any tests created after the upgrade are not affected.

    Code Info

    Systems that have been upgraded from Version 9 or below to Version 10 or above.

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of PR, MN, NE, FL, IL, CA, NY, ND, AR, WI, SD, TN, MO, MA, TX, MT, OH, MI, IA, NJ, CT, NC, UT, WV, GA, CO, PA, AL, DC, NV, DE, WA, OR, IN, SC, HI, MS, KS, ID, MD, LA, NH, VA, ME, AK, VT, OK, AZ, KY, NM, RI and the countries of AFGHANISTAN, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BELGIUM, BOLIVIA, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALY, KENYA, KOREA, REPUBLIC OF, KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, OMAN, PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, Republic of Macedonia, SAUDI ARABIA, Serbia, SINGAPORE, Slovakia, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA.

    Quantity

    600