Z-1007-2009

Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")

Name: Z-1007-2009 Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
Creator: Welch Allyn Protocol, Inc
Published: 2008-12-15
License: https://open.fda.gov/license/

Welch Allyn Protocol, Inc. / initiated 2008-12-15 / Terminated / root cause: manufacturing process

FDA source

Welch Allyn Protocol, Inc began a recall of Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10") on 2008-12-15. The reason FDA records is "Potential for device to deliver less than the programmed energy". 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-1007-2009
Status: Terminated
Initiated: 2008-12-15
Posted: 2009-03-10
Terminated: 2012-03-19
Recalling firm: Welch Allyn Protocol, Inc.
Product: Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Potential for device to deliver less than the programmed energy.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Welch Allyn notified distributors by letter on 12/15/2008 requesting that they notify their customers. Welch Allyn sent an Urgent: Medical Device Recall letter to distributors and customers on February 26, 2009.
Quantity in commerce: 14,012 devices
Distribution: Worldwide distribution.
Product codes and lots: Affected serial numbers are listed on http://www.welchallyn.com/AED10Recall

Product code MKJ

K021168Class IIIJump Start, Model 970300Medical Research Laboratories, Inc. / cleared 2002-06-26

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)