FDA-Device2021-06-02Class II

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).

Welch Allyn Inc
Hazard

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

Sold states
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
Affected count
119770 units
Manufactured in
4341 State Street Rd, N/A, Skaneateles Falls, NY, United States
Products
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).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1673-2021

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