Philips Electronics North America Corporation recalls HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical…

Recall date

February 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0978-2018

FDA classification

Class III

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

Foreign Only - China

Why it was 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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.