Events

Recall of Device Recall LIFEPAK 500 AED

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Physio Control, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59109
  • Event Risk Class
    Class 2
  • Event Number
    Z-2885-2011
  • Event Initiated Date
    2011-06-06
  • Event Date Posted
    2011-07-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101221
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Reason
    The potential reliability issue is the result of a design characteristic of a sram (static random access memory) electronic component on the main printed circuit board assembly.
  • Action
    Physio-Control, Inc. sent an "URGENT- ACTION REQUIRED" letter dated June 2011 to all affected customers. The letter describes the product, problem, and the action to be taken by the customer. The letter recommends that users who store their device(s) in hard-shelled carrying cases remove them from the case(s)immediately and discontinue the use of the case(s). Additionally, the letter recommends that customers perform regular maintenance in accordance with the Operating Instructions. A Confirmation Sheet was enclosed with the letter for customers to complete and return via fax at 1-866-448-9567. Customers can call the Technical Support Team at 1-800-442-1142, Option 5.

Device

Device Recall LIFEPAK 500 AED
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Argentina, Australia, Bahamas, Brazil, Canada, Chile, Columbia, Germany, Hong Kong, Iran, Japan, Mexico, Netherlands, Peru, and Uruguay.
  • Product Description
    The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. || This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient. || The LIFEPAK 500 AED is intended for use in the pre-hospital and workplace and community environments. It has been tested to RTCA/DO-160D; "Environmental Conditions and Test Procedures for Airborne Equipment" (refer to Specifications on page 5-15 of the Operating Instructions 3005338-001). The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and have, at a minimum, the following skills and training: -CPR training -AED training equivalent to that recommended by the American Heart Association -Training in the use of the LIFEPAK 500 AED.
  • Manufacturer
    Physio Control, Inc.

Manufacturer

Physio Control, Inc.
  • Manufacturer Address
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA