Z-0608-2020Class II

HeartStart XL+ Defibrillator/Monitor, Model 861290

Name: Z-0608-2020 HeartStart XL+ Defibrillator/Monitor, Model 861290
Creator: Philips North America, LLC
Published: 2019-10-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-10-03 / Terminated / root cause: manufacturing process

FDA source

Philips North America, LLC began a recall of HeartStart XL+ Defibrillator/Monitor, Model 861290 on 2019-10-03. FDA classified it as Class II and gives the reason as "Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0608-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-03
Posted: 2019-12-05
Terminated: 2023-04-19
Recalling firm: Philips North America LLC
Product: HeartStart XL+ Defibrillator/Monitor, Model 861290
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device will indicate that it is not ready for use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Philips Healthcare issued Medical Device Correction Notices dated 10/3/2019 to customers via certified mail. Customers are advised to take the following actions: - The device is safe to use and can remain in service if it does not exhibit any of these behaviors described in this notice. - If you identify a device that exhibit these behaviors, please remove the device from service and contact Philips to request device. - Fill out, sign and send the reply form that is provided as the last page of the letter.
Quantity in commerce: 24,738 units
Distribution: US Nationwide
Product codes and lots: All Units, Model number 861290

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0608-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0608-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-11	2019-12-05

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)