FDA-Device2020-06-03Class II
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation
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 including in the states of KY, MA, ND, NY and the countries of United Kingdom, Bahrain.
Affected count
130 units (US 126; OUS 4)
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2137-2020Don't want to check this manually?
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