Z-1006-2009

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

Name: Z-1006-2009 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: design

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 "Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1006-2009
Status: Terminated
Initiated: 2008-12-15
Posted: 2009-03-09
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: Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: 10, 735
Distribution: Worldwide Distribution.
Product codes and lots: 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 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)