Events

Recall of Welch Allyn AED 10 Defibrillator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MRL, Inc., A Welch Allyn Company.

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
    28880
  • Event Risk Class
    Class 2
  • Event Number
    Z-0918-04
  • Event Initiated Date
    2004-04-26
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32679
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code MKJ--
  • Reason
    A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the aed10 defibrillator.
  • Action
    Urgent Medical Device Recall letters dated 4/26/04 were sent to the end users via certified mail on 4/26/04. The letters informed the users of the intemittent shock (fire or 3) button failure on the AED 10. The letters included a list of the affected serial numbers, and requested the users to call Welch Allyn MRL Technical Support as soon as possible at 1-800-462-0777 for a replacement AED 10 and to answer any questions. A replacement AED 10 will be sent to the end users within 10 days, and the users were requested to return their AED 10 in the same shipping box accompanying the replacement unit. A follow-up letter will accompany the replacement unit with instructions on how to verify the affected units, packing instructions for the return of the affected units to Welch Allyn MRL, and a correction response form to be completed and enclosed with the returned unit.

Device

Welch Allyn AED 10 Defibrillator
  • Model / Serial
    part numbers 970300 and 970302; serial numbers 4613, 4888/4891, 4897, 6369/6386, 6396/6704, 6706, 6709/6743, 6745/6803, 6806, 6807, 6809, 6811, 6813/6832, 6836/6838, 6853/6855, 6912, 6914, 6917, 6921, 6922, 6924/6926
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide, and internationally to the United Kingdom, Ireland, Singapore, France and South Africa.
  • Product Description
    Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL, Inc., A Welch Allyn Company, 100 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED10, part numbers 970300 (defibrillator) and 970302 (defibrillator with soft shell carrying case)
  • Manufacturer
    MRL, Inc., A Welch Allyn Company

Manufacturer

MRL, Inc., A Welch Allyn Company
  • Manufacturer Address
    MRL, Inc., A Welch Allyn Company, 1000 Asbury Dr Ste 17, Buffalo Grove IL 60089-4551
  • Source
    USFDA