—#161567

Product

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 product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K110825
Affected lot / code info: HeartStart XL+ Defibrillator/Monitor,All Chinese XL manufactured before September, 2017, unless the XL+ is affected by F5N86100172, and has not been updated.

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Foreign Only - China

Timeline

Recall initiated: 2018-02-07
Terminated: 2020-02-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161567. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.