Z-0978-2018Class III

HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by...

Name: Z-0978-2018 HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by...
Creator: Philips Electronics North America Corporation
Published: 2018-02-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-02-07 / Terminated / root cause: labeling and UDI

FDA source

Philips Electronics North America Corporation began a recall of HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of... on 2018-02-07. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0978-2018
Classification: Class III
Status: Terminated
Initiated: 2018-02-07
Posted: 2018-03-13
Terminated: 2020-02-07
Recalling firm: Philips North America LLC
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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 4315
Distribution: Foreign Only - China
Product codes and lots: HeartStart XL+ Defibrillator/Monitor,All Chinese XL manufactured before September, 2017, unless the XL+ is affected by F5N86100172, and has not been updated.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0978-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0978-2018	Class III	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13

Product code MKJ

K110825Class IIIPhilips Heartstart Xl+, Philips Heartstart External Paddles, Philips Multifunction ElectrodesPhilips Medical Systems / cleared 2012-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)