FDA Medical Device Recalls (openFDA)
MRL, Inc., A Welch Allyn Company: Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part 972200
- Recall number
- Z-1106-06
- Recalling firm
- MRL, Inc., A Welch Allyn Company
- Product
- Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part 972200
- Status
- Terminated
- Initiated
- 2006-06-15
- Posted
- 2006-06-22
- Terminated
- 2007-07-19
- Reason
- The Welch Allyn AED 20 Defibrillators may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
- Root cause
- Nonconforming Material/Component
- Action
- MRL issued a press release on 6/15/06, and began sending Urgent Medical Device Recall letters on the same date to the direct accounts informing them of the possibility of the defibrillator going into a terminal failure due to a U25 IC socket susceptible to defibrillation circuit board communication errors. The accounts were asked to respond to the notification witihin 5 working days by faxing or mailing the enclosed response form, or calling Welch Allyn-MRL Technical Support at 1-800-462-0777. A loaner AED 20 will then be sent to the consignee with instrucitons on how to return their unit for correction.
- Quantity
- 580 units
- Distribution
- Worldwide-including USA, Australia, Canada, China, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Nicaragua, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, United Arab Emirates and the United Kingdom.
- Lot, serial or model codes
- Model AED20, catalog #972211, 972212, 972213, 972214, 972215 and 972216; serial numbers 205199 through 205786, except for 205213, 205236, 205237, 205238, 205239, 205240, 205242, 205243, 205247, 205307, 205308, 205309, 205465, 205653, 205654, 205656, 205664, 205665, 205667, 205669, 205677, 205678, 205684, 205703, 205708, 205719, 205732, 205736, 205754, 205756, 205760, 205762, 205763, 205764, 205767, 205774, 205775, 205777, 205781, 205782, 205784. Also included in the recall are serial numbers 201784, 202804, 205179, 205790, 205806, 205808, 205818, 205842, 205866, 206076, 206078, 206079, 206080, 206081, 206096, 206125, 206131, 206137, 206138, 206140, 206162, 206164, 206175, 206177, 206180, 206216, 207511, 207518, 207520, 207521, 207522.
- 510(k) numbers
- ["K002232"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1418729
- Firm city
- Buffalo Grove
- Firm state
- IL
- 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