BEUDAMED
    FDA Enforcement Class II Terminated

    ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP).

    Recall: Z-1673-2021 · Reported June 2, 2021

    Enforcement

    Recall Number
    Z-1673-2021
    Event ID
    87749
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Welch Allyn Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 2, 2021
    Initiation Date
    April 22, 2021
    Classification Date
    May 21, 2021
    Termination Date
    May 31, 2024
    Address
    4341 State Street Rd, N/A, Skaneateles Falls, NY, 13153-5300, United States

    Description

    ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP).

    Reason

    Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock

    Code Info

    All serial numbers

    Distribution

    Worldwide - US Nationwide distribution Foreign: Afghanistan Albania Algeria American Samoa Argentina Australia Austria Azerbaijan Bahamas (the) Bahrain Bangladesh Barbados Belgium Bermuda Bhutan Bolivia (Plurinational State of) Botswana Brazil Brunei Darussalam Bulgaria Cameroon Canada Chad Chile China Colombia Congo (the Democratic Republic of the) Congo (the) Costa Rica Croatia Cyprus Czechia Denmark Dominican Republic (the) Ecuador Egypt El Salvador Estonia Eswatini Finland France French Polynesia Georgia Germany Ghana Greece Guam Guatemala Honduras Hong Kong Hungary Iceland India Indonesia Iran (Islamic Republic of) Iraq Ireland Israel Italy Jamaica Japan Jordan Kenya Korea (the Republic of) Kuwait Lao People's Democratic Republic (the) Latvia Lebanon Lesotho Libya Luxembourg Malaysia Maldives Malta Mexico Mozambique Myanmar Namibia Nepal Netherlands (the) New Zealand Nicaragua Nigeria Northern Mariana Islands (the) Norway Oman Pakistan Panama Paraguay Peru Philippines (the) Poland Portugal Puerto Rico Qatar R¿union Romania Russian Federation (the) Saudi Arabia Senegal Serbia Singapore Slovenia South Africa Spain Sri Lanka Sweden Switzerland Taiwan (Province of China) Thailand Trinidad and Tobago Tunisia Turkey Uganda Ukraine United Arab Emirates (the) United Kingdom Venezuela (Bolivarian Republic of) Viet Nam

    Quantity

    119770 units