Recall Z-0978-2018— Philips Electronics North America Corporation

Name: FDA recall Z-0978-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-07

Class III · Terminated

Class III FDA medical device recall by Philips Electronics North America Corporation, initiated 2018-02-07, terminated 2020-02-07. It names one FDA 510(k) clearance: K110825. Product: HeartStart XL+ Defibrillator/Monitor 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. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED. When operating in Monitor, Manual Defib, or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.. Reason: Update XL¿ device software to version A.03. This includes enhancements to the Operational Checks, event logs, and troubleshooting messages that provide as complete of information as needed to users on device readiness..

Recalling firm: Philips Electronics North America Corporation
Classification: Class III
Status: Terminated
Initiated: 2018-02-07
Terminated: 2020-02-07
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 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. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED. When operating in Monitor, Manual Defib, or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.

Reason for recall

Update XL¿ device software to version A.03. This includes enhancements to the Operational Checks, event logs, and troubleshooting messages that provide as complete of information as needed to users on device readiness.

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