Z-1223-2007

Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator...

Name: Z-1223-2007 Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator...
Creator: Welch Allyn Protocol, Inc
Published: 2007-08-23
License: https://open.fda.gov/license/

Welch Allyn Protocol, Inc. / initiated 2007-08-23 / Terminated / root cause: manufacturing process

FDA source

Welch Allyn Protocol, Inc began a recall of Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company... on 2007-08-23. The reason FDA records is "Failure to deliver therapy: The Welch Allyn AED20 Defibrillators may display a "Defib Comm" error message on the device display during use which may result in failure of the device to analyze the patient's ECG and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1223-2007
Status: Terminated
Initiated: 2007-08-23
Posted: 2007-09-19
Terminated: 2011-09-26
Recalling firm: Welch Allyn Protocol, Inc.
Product: Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E)
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Failure to deliver therapy: The Welch Allyn AED20 Defibrillators may display a "Defib Comm" error message on the device display during use which may result in failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 8/23/07 the firm sent a press release to the Associated Press for release. On 8/29/07 the firm began sending URGENT MEDICAL DEVICE RECALL letters to their consignees informing them of the possibility of the defibrillator to fail to resuscitate the patient. The accounts were asked to respond to the notification within 5 working days by faxing or mailing an enclosed response. End users will be provided with a loaner device while their unit is being serviced. Distributors were sent a separate letter request they provide their customer names to the firm so that the firm can send letters to those customers.
Quantity in commerce: 1,637 devices
Distribution: Worldwide to include USA, Australia, New Zealand, South Africa, China, Hong Kong, Taiwan, Malaysia, Singapore, Phillippines, South Korea, Viet Nam, Egypt, France, Germany, Ireland, India, Israel, Pakistan, Poland, Russia, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom, Canada, Ecuador, Puerto Rico, and South America.
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Product code MKJ

K002232Class IIIAedefibrillatorMedical Research Laboratories, Inc. / cleared 2000-12-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)