FDA-Device2020-06-03Class II
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Philips North America, LLC
Hazard
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
Sold states
Worldwide distribution - US Nationwide distribution and the countries of China, Republic of Korea, Netherlands, Norway, United Kingdom.
Affected count
260 units
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2157-2020Don't want to check this manually?
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