Events

Recall of Device Recall LIFEPAK

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

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
    29025
  • Event Risk Class
    Class 2
  • Event Number
    Z-1107-04
  • Event Initiated Date
    2004-05-05
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32993
  • 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
    Therapy cable doesn't meet firm's standards/may not maintain connections sufficient to support ecg monitoring, external pacing or defibrillation; ecg connector with higher than normal connection resistance resulting in intermittent ecg signal; therapy connector has potential for impact damage.
  • Action
    The firm reviewed records and/or contacted customers by telephone to verify affected devices used in the out of hospital mobile environment. All affected customers were notified by a letter dated May 2004. The firm''s service representative will contact customers to inspect and correct the devices.

Device

Device Recall LIFEPAK
  • Model / Serial
    Non-continuous Serial Numbers between 1178083 and 305080962.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    The firm distributes to distributors, hospitals, EMT-Ds and paramedics nationwide. The firm also distibutes the product internationally.
  • Product Description
    LIFEPAK 12 defibrillator/monitor || Part Numbers: || VLP12-02-000000 through VLP12-02-005003, || AVLP12-02-000000 through AVLP12-02-005003, || DVLP12-02-000000 through DVLP12-02-005003, || EVLP12-02-000000 through EVLP12-02-005003, || FVLP12-02-000000 through FVLP12-02-005003, || LVLP12-02-000000 through LVLP12-02-005003, || PVLP12-02-000000 through PVLP12-02-005003, || UVLP12-02-000000 through UVLP12-02-005003
  • Manufacturer
    Medtronic Physio Control Corp

Manufacturer

Medtronic Physio Control Corp
  • Manufacturer Address
    Medtronic Physio Control Corp, 11811 Willows Rd NE, Redmond WA 98073
  • Source
    USFDA