Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
This recall has been terminated (originally issued March 10, 2009).
- Company
- Welch Allyn Protocol, Inc
- Recall Initiated
- December 15, 2008
- Posted
- March 10, 2009
- Terminated
- March 19, 2012
- Recall Number
- Z-1007-2009
- Quantity
- 14,012 devices
- Firm Location
- Beaverton, OR
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for device to deliver less than the programmed energy.
Distribution
Worldwide distribution.
Lot / Code Info
Affected serial numbers are listed on http://www.welchallyn.com/AED10Recall
Root 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.
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