Reported Mar 5, 2014 · Terminated

Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting…

Philips Medical Systems, Inc.

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 Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • Philips HeartStart XL+
  • Defibrillator/Monitor Model861290 The 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 NumbersSerial Number Range
    • USO1100106-USO1100372
    • USN1100376-USN1100960
    • USD1100961-USD1101095
    • US11201095-US11201186
    • US21201187-US21201239
    • US31201240-US31201537
    • US41201538-US41201585
    • US51201586-US51201721
    • US61201722-US61201924
    • US71201925-US71202048
    • US81202049-US81202168
    • US91202169-US91202514
    • US01202515-US01202990
    • USN1202991-USN1203537
    • USD1203538-USD1203968
    • US11303969-US11303972
    • US21303980-US21304488
    • US31304489-US31305042
    • US41305043-US41305295
    • US51305296-US51305450
    • US61305451-US61306138
    • US71306139-US71306542
    • US81306543-US81306998
    • US91306999-US91307261
    • US01307306-US01307458
Amount recalled
7157 units

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the specified 3 hour duration as stated in the labeling

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 3, 2020 · Data as of Sep 19, 4:46 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.