Recall Z-1914-2018— Philips Electronics North America Corp.

Name: FDA recall Z-1914-2018
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: K020715. Product: Philips HeartStart (HS1) Onsite/Home 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

K020715 — PHILIPS M5066A AND M5068APhilips Medical Systems·cleared 2002-11-08

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 (HS1) Onsite/Home 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.