Medical device recalls Moderate risk

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

Recall date
October 16, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0498-2020
FDA classification
Class II
Brand / firm
Philips North America, LLC
Sold / distributed
US Nationwide

Why it was recalled

The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user.

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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