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.
FDA Recall Z-0978-2018 · Posted None
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Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2018-02-07
Date Terminated2020-02-07
Product Quantity4315
Reason for Recall
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.
Firm Action
Philips is initiating a correction to affected devices. A software upgrade is available free of charge for all units affected by the issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrades. Customers may continue to use XL+ prior to receiving the software upgrade. For further questions, please call (978) 659-3000.
Root Cause
Labeling mix-ups
Distribution Pattern
Foreign Only - China
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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