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Philips North America, LLC recalls HeartStart XL+ Defibrillator/Monitor, Model 861290
Recalled December 11, 2019 · FDA recall Z-0608-2020 · Philips North America
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. · FDA Class II
Units
24,738 units
Sold at
US Nationwide
Description
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.
Product
HeartStart XL+ Defibrillator/Monitor, Model 861290
Manufacturer(s)
Philips North America, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →