—#177814

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, Model number 861290

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2019-10-03
Terminated: 2023-04-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177814. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.