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
    51496
  • Event Risk Class
    Class 2
  • Event Number
    Z-1389-2009
  • Event Initiated Date
    2009-02-26
  • Event Date Posted
    2009-06-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80550
  • 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
    Issue #1: aed 10 displayed a "do not use" symbol as a result of a blown f1 fuse. issue #2: aed 10 models that incorporate a spring connector with the speaker experienced intermittent electrical connection to the circuit board causing a loss of voice prompts.
  • Action
    Welch Allyn sent an Urgent Medical Device Recall letter dated February 26, 2009 to all distributors and customers, describing 5 failure modes. Customers were instructed to respond to the letter by calling 888-345-5356, and decide on replacement or discounted new purchase.

Device

Device Recall AED 10
  • Model / Serial
    Blown fuse serial numbers: 008577 - 013143 inclusive. Voice prompt serial numbers: 002002 - 008286 inclusive, and 008289 008291 008293 008296 008297 008298 008299 008300 008301 008302 008303 008304 008305 008306 008307 008308 008309 008310 008311 008312 008313 008314 008315 008316 008322 008323 008324 008325 008326 008327 008328 008329 008330 008331 008332 008333 008334 008335 008336 008337 008339 008340 008362 008363 008364 008365 008366 008367 008368 008369 008370 008372 008373 008374 008375 008376 008377 008378 008379 008402 008403 008404 008405 008406 008407 008411 008413 008414 008415 008416 008417 008418 008419 008420 008421 008422 008423 008424 008425 008426 008427 008428 008429 008430 008431 008432 008435 008446 008524 008525 008583 008656 008671 008712 008714 008724 008742 008743 008744 008792 008856 008864 008911 008913 008943 008988 009007 009009 009010 009015 009016 009017 009066 009067 009070 009071 009072 009073 009074 009075 009076 009079 009081 009083 009085 009086 009087 009122 009123 009124 009126 009127 009128 009129 009130 009139 009715 009813 010108 010168 012603 013659 013665 013727 016604 019508 020910 020911 020912 022356  and 027224.
  • 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