PlainRecalls
FDA Devices Moderate Class II Terminated

HeartStart XL+ Defibrillator/Monitor, Model 861290

Reported: November 27, 2019 Initiated: October 16, 2019 #Z-0498-2020

Product Description

HeartStart XL+ Defibrillator/Monitor, Model 861290

Reason for Recall

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.

Details

Units Affected
23,749 Units
Distribution
US Nationwide
Location
Andover, MA

Frequently Asked Questions

What product was recalled?
HeartStart XL+ Defibrillator/Monitor, Model 861290. Recalled by Philips North America, LLC. Units affected: 23,749 Units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 27, 2019. Severity: Moderate. Recall number: Z-0498-2020.