Events

Recall of Device Recall Welch Allyn AED 20 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
    35587
  • Event Risk Class
    Class 1
  • Event Number
    Z-1106-06
  • Event Initiated Date
    2006-06-15
  • Event Date Posted
    2006-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46430
  • 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 - Product Code MKJ
  • Reason
    The welch allyn aed 20 defibrillators may display a 'defib comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ecg and deliver the appropriate therapy.
  • Action
    MRL issued a press release on 6/15/06, and began sending Urgent Medical Device Recall letters on the same date to the direct accounts informing them of the possibility of the defibrillator going into a terminal failure due to a U25 IC socket susceptible to defibrillation circuit board communication errors. The accounts were asked to respond to the notification witihin 5 working days by faxing or mailing the enclosed response form, or calling Welch Allyn-MRL Technical Support at 1-800-462-0777. A loaner AED 20 will then be sent to the consignee with instrucitons on how to return their unit for correction.

Device

Device Recall Welch Allyn AED 20 Defibrillator
  • Model / Serial
    Model AED20, catalog #972211, 972212, 972213, 972214, 972215 and 972216; serial numbers 205199 through 205786, except for 205213, 205236, 205237, 205238, 205239, 205240, 205242, 205243, 205247, 205307, 205308, 205309, 205465, 205653, 205654, 205656, 205664, 205665, 205667, 205669, 205677, 205678, 205684, 205703, 205708, 205719, 205732, 205736, 205754, 205756, 205760, 205762, 205763, 205764, 205767, 205774, 205775, 205777, 205781, 205782, 205784.  Also included in the recall are serial numbers 201784, 202804, 205179, 205790, 205806, 205808, 205818, 205842, 205866, 206076, 206078, 206079, 206080, 206081, 206096, 206125, 206131, 206137, 206138, 206140, 206162, 206164, 206175, 206177, 206180, 206216, 207511, 207518, 207520, 207521, 207522.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide-including USA, Australia, Canada, China, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Nicaragua, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, United Arab Emirates and the United Kingdom.
  • Product Description
    Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part 972200
  • 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