Events

Recall of Device Recall Lifepak Defribrillator/Monitor

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
    48748
  • Event Risk Class
    Class 2
  • Event Number
    Z-2388-2008
  • Event Initiated Date
    2008-06-18
  • Event Date Posted
    2008-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72055
  • 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
    Dc-defibrillator, low-energy - Product Code MKJ
  • Reason
    Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect and the service light indicator to illuminate.
  • Action
    On 06/18/08 the firm, via regular postal service , mailed an "IMPORTANT MEDICAL DEVICE NOTIFICATION" letter to all their consignees. The letter instructs consignees that the coin battery may deplete prematurely and to contact Physio-Control if their Lifepack 20 defibrillator/monitor requires coin battery replacement prior to the recommended four year replacement schedule. If you have any questions, contact Technical Support at 1-800-442-1142, option 5 from 6:00 am to 4:00 pm (Pacific), Monday-Friday or visit www.physio-control-notices.com/coin battery.

Device

Device Recall Lifepak Defribrillator/Monitor
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    There were 24,238 devices distributed to 3,135 consignees throughout the United States and 20,613 devices distributed to 48 foreign consignees.
  • Product Description
    Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain fatal arrhythmias.
  • 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