Events

Recall of Welch Allyn AED10

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
    45476
  • Event Risk Class
    Class 1
  • Event Number
    Z-0129-2008
  • Event Initiated Date
    2007-10-26
  • Event Date Posted
    2007-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65555
  • 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
    Failure to deliver shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient.
  • Action
    The firm issued a press release on 10/30/07, and has set up a call center for customers, and plans to send three (3) certified mailings to notify affected customers, alert them of the issue, and provide instructions on how to return their device. The first letter dated 10/26/07 was sent via certified mail to customers on 10/26/07. The letter informs customers of the firm recalling the product to correct faulty capacitors on the circuit board, and which could result in a malfunction that prevents or delays delivery of a defibrillating shock. The letter indicates the faulty AED10 devices were manufactured between 3/29/07 and 8/9/07. The letter also indicates the serial numbers affected, and where the serial number is located - upper left hand corner of the back panel of the device. In addition the letter includes a response form, the firm's contact information, and indicates that the firm will exchange the recalled defibrillator with a replacement and new five (5) year warranty.

Device

Welch Allyn AED10
  • Model / Serial
    Serial numbers of units affected: NA036960, NA036970, NA037000, NA037004, NA037005, NA037009, NA037010, NA037012, NA037014, NA037015, NA037020, NA037022, NA037025, NA037027, NA037029, NA037030, NA037030, NA037031, NA037032, NA037034, NA037035, NA037036, NA037044, NA037045, NA037046, NA037048, NA037050, NA037051, NA037052, NA037053, NA037056, NA037057, NA037058, NA037088, NA037090, NA037091, NA037092, NA037093, NA037094, NA037095, NA037097, NA037098, NA037108, NA037110, NA037111, NA037112, NA037114, NA037115, NA037116, NA037118, NA037119, NA037120, NA037121, NA037122, NA037123, NA037124, NA037125, NA037126, NA037127, NA037128, NA037129, NA037132, NA037134, NA037139, NA037140, NA037143, NA037145, NA037146, NA037147, NA037148, NA037149, NA037150, NA037154, NA037155, NA037157, NA037158, NA037159, NA037160, NA037161, NA037162, NA037163, NA037164, NA037166, NA037167, NA037168, NA037169, NA037170, NA037171, NA037172, NA037173, NA037174, NA037175, NA037177, NA037179, NA037180, NA037182, NA037183, NA037184, NA037185, NA037186, NA037187, NA037188, NA037189, NA037190, NA037193, NA037194, NA037203, NA037206, NA037207, NA037209, NA037210, NA037213, NA037217, NA037219, NA037220, NA037221, NA037223, NA037225, NA037228, NA037234, NA037256, NA037354, NA037499, NA037511, NA037512, NA037513, NA037515, NA037516, NA037517, NA037518, NA037519, NA037523, NA037524, NA037525, NA037532, NA037533, NA037534, NA037535, NA037536, NA037538, NA037539, NA037540, NA037541, NA037542, NA037543, NA037544, NA037545, NA037546, NA037547, NA037548, NA037549, NA037550, NA037551, NA037552, NA037553, NA037554, NA037555, NA037556, NA037557, NA037558, NA037559, NA037560, NA037561, NA037562, NA037563, NA037564, NA037565, NA037566, NA037567, NA037568, NA037569, NA037570, NA037571, NA037572, NA037573, NA037574, NA037575, NA037576, NA037577, NA037578, NA037579, NA037580, NA037581, NA037582, NA037583, NA037584, NA037585, NA037586, NA037587, NA037588, NA037589, NA037590, NA037591, NA037592, NA037593, NA037594, 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  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide.
  • Product Description
    Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers: 970302E,970308E,970309E, 970310E and 970311E;
  • 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