Recall Z-1913-2018— Philips Electronics North America Corp.

Name: FDA recall Z-1913-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-14

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corp., initiated 2018-03-14, terminated 2020-08-19. It names one FDA 510(k) clearance: K050004. Product: Philips HeartStart FRx AED.. Reason: An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed..

Recalling firm: Philips Electronics North America Corp.
Classification: Class II
Status: Terminated
Initiated: 2018-03-14
Terminated: 2020-08-19
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K050004 — PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304Philips Medical Systems·cleared 2005-02-25

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

Philips HeartStart FRx AED.

Reason for recall

An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.

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