Recall Z-1007-2009
Welch Allyn Protocol, Inc · initiated December 15, 2008
Product
Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
Codes / lots: Affected serial numbers are listed on http://www.welchallyn.com/AED10Recall
Reason for recall
Potential for device to deliver less than the programmed energy.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1007-2009
- Initiated
- December 15, 2008
- Posted by FDA
- March 10, 2009
- Terminated
- March 19, 2012
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 14,012 devices
- Distribution
- Worldwide distribution.
- Recalling firm
- Welch Allyn Protocol, Inc, Beaverton, OR