FDA-Device2019-12-11Class II
HeartStart XL+ Defibrillator/Monitor, Model 861290
Philips North America, LLC
Hazard
Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device will indicate that it is not ready for use.
Sold states
US Nationwide
Affected count
24,738 units
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
HeartStart XL+ Defibrillator/Monitor, Model 861290
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0608-2020Don't want to check this manually?
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