FDA-Device2021-10-20Class II
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Philips North America LLC
Hazard
Customers were not notified of previous recalls associated with various defibrillator models.
Sold states
U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.
Affected count
4 units
Manufactured in
22100 Bothell Everett Hwy, N/A, Bothell, WA, United States
Products
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0078-2022Don't want to check this manually?
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