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-1007-2009
- 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
- 2009-03-10
- Terminated
- 2012-03-19
- Reason
- Potential for device to deliver less than the programmed energy.
- 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
- 14,012 devices
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- Affected serial numbers are listed on http://www.welchallyn.com/AED10Recall
- 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