Recall Z-0608-2020— Philips North America, LLC

Name: FDA recall Z-0608-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-03

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2019-10-03, terminated 2023-04-19. It names one FDA 510(k) clearance: K110825. Product: HeartStart XL+ Defibrillator/Monitor, Model 861290. Reason: 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..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-10-03
Terminated: 2023-04-19
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K110825 — PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODESPhilips Medical Systems·cleared 2012-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

HeartStart XL+ Defibrillator/Monitor, Model 861290

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.