Events

Recall of Device Recall LIFEPAK 500

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Emergency Response Systems, 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
    38232
  • Event Risk Class
    Class 2
  • Event Number
    Z-1148-2007
  • Event Initiated Date
    2007-06-13
  • Event Date Posted
    2007-08-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53210
  • 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
    Defibrillator automated external biphasic - Product Code MKT
  • Reason
    Reduced shock- the device may deliver 100 joule (j) to a patient, which is less than the recommended factory minimum default setting of 200 j.
  • Action
    On June 13, 2007 the recalling firm sent a letter dated June 11, 2007, titled URGENT - MEDICAL DEVICE CORRECTIVE ACTION. The letter advises of the situation, recommends to the consignee to set defibrillator to FIXED Sequence Protocol and to contact the firm for a FLEXIBLE Sequence Energy Protocol. The letter provides an instruction sheet and a response sheet to be faxed back to the company.

Device

Device Recall LIFEPAK 500
  • Model / Serial
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)
  • Manufacturer
    Medtronic Emergency Response Systems, Inc.

Manufacturer

Medtronic Emergency Response Systems, Inc.
  • Manufacturer Address
    Medtronic Emergency Response Systems, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Source
    USFDA