LifePak 600 Automated External Defibrillator

• • Terminated Z-1082-2013 FDA Class II ·initiated 8 Feb 2013

  LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.

• • Terminated Z-2030-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2009

  The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly humid environment. K1 shorting may affect the ECG amplitude causing the Shock Advisory System(SAS) to not analyze the ECG rhythm correctly thus preventing the device from delivering therapy.

• • Terminated Z-2341-2008 FDA Unclassified (pre-2012) ·initiated 28 Aug 2008 ·on shared 510(k) K011144

  This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic device. Fully automatic defibrillators h

• 2 recalls, same reason

  • Terminated Z-0149-2009 FDA Unclassified (pre-2012) ·initiated 24 Jul 2008
  • Terminated Z-0150-2009 FDA Unclassified (pre-2012) ·initiated 24 Jul 2008

  The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.

• • Terminated Z-0671-2007 FDA Unclassified (pre-2012) ·initiated 2 Mar 2007

  LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement.

• 2 recalls, same reason

  • Terminated Z-0837-2007 FDA Unclassified (pre-2012) ·initiated 5 Oct 2006
  • Terminated Z-0836-2007 FDA Unclassified (pre-2012) ·initiated 5 Oct 2006

  Premature battery depletion due to electrical component failure

• • Terminated Z-0940-03 FDA Unclassified (pre-2012) ·initiated 23 May 2003

  Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K011144 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• LifePak 12 Defibrillator/Monitor System

  Class III

  FDA 510(k) K010918 Active Cleared 23 Aug 2001

• Lifepak 12

  Class III

  FDA 510(k) K040775 Active Cleared 23 Apr 2004

• LifePak 500 Automated External Defibrillator

  Class III

  FDA 510(k) K012428 Active Cleared 28 Sep 2001

• Lifepak 12DEFIBERLLATOR/Monitor Series

  Class III

  FDA 510(k) K002445 Active Cleared 31 Jan 2001

• Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker

  Class II

  FDA 510(k) K012274 Active Cleared 5 Feb 2002

• LifePak 12, 20, 500, CR Plus

  Class III

  FDA 510(k) K033275 Active Cleared 6 Nov 2003

See all devices from Medtronic Physio-Control Corp. →

• Is the LifePak 600 Automated External Defibrillator intended for reuse, or is it strictly single-use?

  The LifePak 600 is supplied as a sterile, non-reusable unit for single-use in emergency cardiac resuscitation. However, the manufacturer provides guidelines for reuse, allowing it to be used again under specific conditions outlined by Medtronic Physio-Control Corp.

• What are the key storage requirements for the LifePak 600 Automated External Defibrillator?

  The LifePak 600 does not require special storage conditions beyond protecting it from physical damage. It is designed for use in both pre-hospital and in-hospital settings, so standard storage practices for medical devices in these environments apply.

• How was the regulatory pathway for the LifePak 600 Automated External Defibrillator determined, and which committee was involved?

  The LifePak 600 received FDA clearance through a 510(k) submission, classified as substantially equivalent under the Cardiovascular (CV) advisory committee. The device is regulated under 21 CFR 870.5310, confirming its classification as a Class III medical device.

• What types of cardiac emergencies is the LifePak 600 Automated External Defibrillator designed to address?

  The LifePak 600 is specifically designed to analyze heart rhythms and deliver an electric shock to restore normal sinus rhythm in patients experiencing sudden cardiac arrest, including ventricular fibrillation or pulseless ventricular tachycardia.

• How is the LifePak 600 Automated External Defibrillator supplied, and what does this mean for its handling?

  The device is supplied as a sterile, non-reusable unit, meaning it is pre-packaged for immediate use without requiring additional sterilization. This ensures readiness for emergency cardiac resuscitation while minimizing contamination risks during deployment.