Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
FDA device recall Z-1007-2009 · posted 2009-03-10 · Terminated
Recall details
- Recalling firm
- Welch Allyn Protocol, Inc
- Reason for recall
- Potential for device to deliver less than the programmed energy.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 14,012 devices
- Distribution
- Worldwide distribution.
- Date initiated
- 2008-12-15
- Date posted
- 2009-03-10
- Date terminated
- 2012-03-19
- Location
- Beaverton, OR
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JUMP START, MODEL 970300 (K021168) | Medical Research Laboratories, Inc. | 2002-06-26 |