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Recall Observatory FDA recall evidence

Device product

HeartStart XL+ Defibrillator/Monitor, Model 861290

Z-0608-2020

October 03, 2019

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 84236
Status
Terminated
Classification
Class II
Quantity
24,738 units
Official record key
device-enforcement:Z-0608-2020

Official wording

Reason: 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.

Code information: All Units, Model number 861290

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.