Events

Recall of Device Recall The LIFEPAK 15 monitor/defibrillator

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
    75743
  • Event Risk Class
    Class 2
  • Event Number
    Z-0761-2017
  • Event Initiated Date
    2010-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151125
  • 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
    Customer complaint was received relating to a lifepak15 device that would power on then power down unexpectedly after a short period of use. when the lp15 powered down, power could be immediately restored by activation of the power button. the device was connected to a cellular modem from multitech systems for use with life net services. the corrective action was completed by velocitor solutions in december 2010.
  • Action
    Velocitor initiated this field action and notified affected customers on March 11, 2010. This action was reported to Physio-Control as completed on 12/21/2010.

Device

Device Recall The LIFEPAK 15 monitor/defibrillator
  • Model / Serial
    This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    worldwide
  • Product Description
    The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical || personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX
  • 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