Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use Recalled by Philips Electronics North America Corporation Due to Update XL¿ device software to version A.03. This...

Date: February 7, 2018
Company: Philips Electronics North America Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Electronics North America Corporation directly.

Affected Products

HeartStart XL+ Defibrillator/Monitor 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. It must be used by or on the order of a physician. 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 use of an AED. When operating in Monitor, Manual Defib, or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.

Quantity: 4315

Why Was This Recalled?

Update XL¿ device software to version A.03. This includes enhancements to the Operational Checks, event logs, and troubleshooting messages that provide as complete of information as needed to users on device readiness.

Where Was This Sold?

Foreign Only - China

About Philips Electronics North America Corporation

Philips Electronics North America Corporation has 160 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report