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Philips North America, LLC recalls HeartStart XL+ Defibrillator/Monitor, Model 861290
Recalled November 27, 2019 · FDA recall Z-0498-2020 · Philips North America
Hazard
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. · FDA Class II
Units
23,749 Units
Sold at
US Nationwide
Description
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.
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 →