Reported Dec 11, 2019 · Terminated

HeartStart XL+ Defibrillator/Monitor, Model 861290

Philips North America, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • HeartStart XL+ Defibrillator/Monitor, Model 861290
Lot codes and dates
  • All Units, Model number 861290
Amount recalled
24,738 units

Where it was sold

  • 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 19, 2023 · Data as of Sep 19, 6:16 PM UTC

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