Events

Recall of Device Recall AED 10

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Welch Allyn Protocol, 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
    50146
  • Event Risk Class
    Class 1
  • Event Number
    Z-1006-2009
  • Event Initiated Date
    2008-12-15
  • Event Date Posted
    2009-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74818
  • 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 defibrillator - Product Code MKJ
  • Reason
    Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;.
  • Action
    Welch Allyn sent a Customer Recall Notice dated February 26, 2009, to all customers (customer list supplied by distributors). Welch Allyn will upgrade all units with software version 2.02 and lower to version 2.06.02 by Proc. AED10 Prod Service Min HW/SW Update Rev. E 820-0178-00.

Device

Device Recall AED 10
  • Model / Serial
    Software version 2.02 or lower. The ECG analysis/noise issue involves all units manufactured before January 2006 when a design/component change was made.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
  • Manufacturer
    Welch Allyn Protocol, Inc

Manufacturer

Welch Allyn Protocol, Inc
  • Manufacturer Address
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA