Recall Z-1438-2014— Philips Medical Systems, Inc.

Name: FDA recall Z-1438-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-02

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-04-02, terminated 2020-09-16. It names one FDA 510(k) clearance: K110825. Product: Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.. Reason: Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-04-02
Terminated: 2020-09-16
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

Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.

Reason for recall

Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy.

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