Recall Z-0871-2013— Philips Healthcare Inc.

Name: FDA recall Z-0871-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-28

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2013-01-28, terminated 2020-09-03. It names one FDA 510(k) clearance: K110825. Product: Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. Reason: Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use.

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-28
Terminated: 2020-09-03
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 Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation

Reason for recall

Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use

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