Welch Allyn Protocol, Inc Welch Allyn AED 10 automatic 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 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")
Brand
Welch Allyn Protocol, Inc
Lot Codes / Batch Numbers
software versions 2.03, 2.04, 2.05, and 2.06
Products Sold
software versions 2.03, 2.04, 2.05, and 2.06
Welch Allyn Protocol, Inc is recalling Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10") due to Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
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 noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026