Events

Recall of Device Recall The LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators (AEDs)

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
    64427
  • Event Risk Class
    Class 2
  • Event Number
    Z-1082-2013
  • Event Initiated Date
    2013-02-08
  • Event Date Posted
    2013-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116122
  • 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
    Lifepak cr plus or lifepak express automated external defibrillators (aeds) are recalled due to the potential to experience an early internal battery depletion issue.
  • Action
    The firm start sending the "URGENT MEDICAL DEVICE CORRECTION LIFEPAK CR Plus AND LIFEPAK EXPRESS AEDs" letter, dated February 2013, to their consignees. Consignees are advised to check the readiness of the AEDs and should contact Physio if the OK symbol is NOT visible and either the ATTENTION or WRENCH symbols are present. In the event a device is returned to Physio-Control for assessment, the firm will analyze it to determine if it is affected by the early internal battery depletion issue. If it is verified the device is affected, the consignee will be provided with a permanent replacement device. Customers with questions can visit the firm's website www.physio-control-notices.com/CHARGE-PAK or call Technical Support at 1-800-442-1142.

Device

Device Recall The LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators (AEDs)
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. || Automated external defibrillators.
  • 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