Z-1005-2009

Welch Allyn AED 10 Automated External Defibrillator

Name: Z-1005-2009 Welch Allyn AED 10 Automated External Defibrillator
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 on 2008-12-15. The reason FDA records is "Potential for device to shut down prematurely under certain circumstances". 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-1005-2009
Status: Terminated
Initiated: 2008-12-15
Posted: 2009-03-10
Terminated: 2012-02-15
Recalling firm: Welch Allyn Protocol, Inc.
Product: Welch Allyn AED 10 Automated External Defibrillator
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Potential for device to shut down prematurely under certain circumstances.
Root cause tag: design
FDA root cause: Device Design
Action: On 4/13/07 the firm released Service Bulletin part no. 810-2614-00, SB - AED 10 S/W V020600 DOWNGRADE to V020500. That mandatory bulletin, for units with software version 2.06.00 and up indicates that all returning AED 10 units shall have their software version downgraded to 2.05.00.
Quantity in commerce: 89 units
Distribution: Worldwide distribution: USA, Belgium, Canada, France, Ireland, Israel, Mexico, and United Kingdom.
Product codes and lots: Serial numbers: 002664, 002665, 003449, 003875, 003903, 004108, 004126, 005032, 005096, 005097, 005394, 005438, 006297, 006425, 006728, 006730, 007036, 007039, 007041, 007056, 007057, 007418, 007559, 007999, 008021, 008074, 009474, 009501, 010193, 010194, 010196, 010197, 010387, 011026, 011470, 011834, 011936, 012287, 012659, 012859, 013520, 013928, 014655, 014733, 014927, 015154, 015568, 017521, 017683, 018364, 018777, 018941, 019292, 019619, 020422, 020964, 020965, 021543, 021559, 021643, 022509, 022522, 022545, 022546, 022549, 022578, 022579, 022584, 022596, 022597, 022631, 022641, 022654, 023419, 023420, 023421, 023423, 023697, 024000, 025546, 026137, 026878, NA030786, NA031363, NA031533, NA031857, NA032151, NA032179, NA035807002664, 002665, 003449, 003875, 003903, 004108, 004126, 005032, 005096, 005097, 005394, 005438, 006297, 006425, 006728, 006730, 007036, 007039, 007041, 007056, 007057, 007418, 007559, 007999, 008021, 008074, 009474, 009501, 010193, 010194, 010196, 010197, 010387, 011026, 011470, 011834, 011936, 012287, 012659, 012859, 013520, 013928, 014655, 014733, 014927, 015154, 015568, 017521, 017683, 018364, 018777, 018941, 019292, 019619, 020422, 020964, 020965, 021543, 021559, 021643, 022509, 022522, 022545, 022546, 022549, 022578, 022579, 022584, 022596, 022597, 022631, 022641, 022654, 023419, 023420, 023421, 023423, 023697, 024000, 025546, 026137, 026878, NA030786, NA031363, NA031533, NA031857, NA032151, NA032179, and NA035807.

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)