Z-0498-2020Class II

HeartStart XL+ Defibrillator/Monitor, Model 861290

Name: Z-0498-2020 HeartStart XL+ Defibrillator/Monitor, Model 861290
Creator: Philips North America, LLC
Published: 2019-10-16
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-10-16 / Terminated / root cause: manufacturing process

FDA source

Philips North America, LLC began a recall of HeartStart XL+ Defibrillator/Monitor, Model 861290 on 2019-10-16. FDA classified it as Class II and gives the reason as "The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock...". 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-0498-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-16
Posted: 2019-11-19
Terminated: 2023-11-29
Recalling firm: Philips North America LLC
Product: HeartStart XL+ Defibrillator/Monitor, Model 861290
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On October 16, 2019, Philips Healthcare issued Urgent Medical Device Correction notices to U.S. customers via certified mail. Philips Markets Organizations are responsible for distributing the letters outside of the U.S. Actions to be taken by the customer: 1) The device is safe to use and can remain in service if it does not exhibit any of these behaviors described in this Notice. 2) Continue to perform Shift Checks and Operational checks as recommended in the Instructions for Use (IFU) as this reduces the risk of a failure during use. 3) If you identify a device that exhibit any of these behaviors; please remove it from service and contact Philips to request service. Philips will contact you to arrange for repair of your unit once parts are available. Philips will install a replacement switch in affected devices at no charge to the customer. If you need further information or support concerning this notification, please contact your local Philips representative.
Quantity in commerce: 23,749 Units
Distribution: US Nationwide
Product codes and lots: All units manufactured prior to 1 May 2017.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0498-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0498-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-19

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)