FDA Medical Device Recalls (openFDA)
Welch Allyn Protocol, Inc: Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")
- Recall number
- Z-1656-2009
- Recalling firm
- Welch Allyn Protocol, Inc
- Product
- Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")
- Status
- Terminated
- Initiated
- 2009-04-24
- Posted
- 2009-07-06
- Terminated
- 2011-08-11
- Reason
- Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing soon. If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, thereby causing therapy to
- Root cause
- Labeling design
- Action
- The firm has developed expanded labeling for users and will revise the user manuals for software versins 2.03, 2.04, 2.05, and 2.06. Customers receiving the updated manuals will be sent a cover letter directing them to discard the original user manual and replace it with the updated manual. The April 24, 2009, cover letter will highlight the clarification of directions for use regarding what to do when a low battery indicator is displayed.
- Quantity
- 46740 units
- Distribution
- Worldwide distribution: USA, Guam, Puerto Rico, Canada, Mexico, Andorra, UAE, Afghanistan, Australia, Azerbaijan, Belgium, Belarus, Bermuda, Bahrain, Brazil, British West Indies, Switzerland, China, Cyprus, Czech Republic, Germany, Denmark, Algeria, Egypt, Spain, France, French Guiana, French Lesser Antilles, Greece, Haiti, Hong Kong, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Kenya, Kyrgyz, Lebanon, Lithuania, Luxembourg, Latvia, Monaco, Malaysia, Netherlands, New Zealand, Phillipines, Pakistan, Poland, Portugal, Reunion Island, Russia, Saudi Arabia, Singapore, South Korea, Taiwan, United Kingdom, Uraguay, Yemen, and South America.
- Lot, serial or model codes
- software versions 2.03, 2.04, 2.05, and 2.06
- 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