FDA-Device2019-11-27Class II
HeartStart XL+ Defibrillator/Monitor, Model 861290
Philips North America, LLC
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.
Sold states
US Nationwide
Affected count
23,749 Units
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
HeartStart XL+ Defibrillator/Monitor, Model 861290
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0498-2020Don't want to check this manually?
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