FDA Medical Device Recalls (openFDA)
Welch Allyn Protocol, Inc: Welch Allyn AED 10 Automated External Defibrillator
- Recall number
- Z-1005-2009
- Recalling firm
- Welch Allyn Protocol, Inc
- Product
- Welch Allyn AED 10 Automated External Defibrillator
- Status
- Terminated
- Initiated
- 2008-12-15
- Posted
- 2009-03-10
- Terminated
- 2012-02-15
- Reason
- Potential for device to shut down prematurely under certain circumstances.
- 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
- 89 units
- Distribution
- Worldwide distribution: USA, Belgium, Canada, France, Ireland, Israel, Mexico, and United Kingdom.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K021168"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 3023750
- Firm city
- Beaverton
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28