Medical device recalls Moderate risk

Philips North America, LLC recalls HeartStart XL+ Defibrillator/Monitor, Model 861290

Recall date
October 3, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0608-2020
FDA classification
Class II
Brand / firm
Philips North America, LLC
Sold / distributed
US Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HeartStart XL+ Defibrillator/Monitor, Model 861290

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