Reported Aug 12, 2015 · Terminated

Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital…

Philips Electronics North America Corporation

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 Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • Philips HeartStart XL+
  • Defibrillator/Monitor Product UsageThe HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. When operating in Monitor, Manual Defibrillation or Pacing modes, the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support
Lot codes and dates
  • Serial Numbers in the following ranges
    • USO1100100 to USD1101095
    • US11201096 to USD1203968
    • US11303969 to USD1309471
    • US11409472 to US61414022
Amount recalled
13,168 devices

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Multiple software and hardware issues with device that can affect its function.

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 Feb 25, 2019 · Data as of Sep 19, 6:51 PM UTC

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