FDA Medical Device Recalls (openFDA)
Welch Allyn Protocol, Inc: Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
- Recall number
- Z-1006-2009
- Recalling firm
- Welch Allyn Protocol, Inc
- Product
- Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
- Status
- Terminated
- Initiated
- 2008-12-15
- Posted
- 2009-03-09
- Terminated
- 2012-03-19
- Reason
- Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;
- 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
- 10, 735
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- 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.
- 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