—#177225

Product

HeartStart XL+ Defibrillator/Monitor, Model 861290

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K110825
Affected lot / code info: All units manufactured prior to 1 May 2017.

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2019-10-16
Posted by FDA: 2019-11-19
Terminated: 2023-11-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177225. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.