Welch Allyn Protocol, Inc Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10") Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
Brand
Welch Allyn Protocol, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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.
Welch Allyn Protocol, Inc is recalling Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10") due to Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026