Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
FDA device recall Z-1389-2009 · posted 2009-06-23 · Terminated
Recall details
- Recalling firm
- Welch Allyn Protocol, Inc
- Reason for recall
- Issue #1: AED 10 displayed a "Do Not Use" symbol as a result of a blown F1 fuse. Issue #2: AED 10 models that incorporate a spring connector with the speaker experienced intermittent electrical connection to the circuit board causing a loss of voice prompts.
- Action taken
- Welch Allyn sent an Urgent Medical Device Recall letter dated February 26, 2009 to all distributors and customers, describing 5 failure modes. Customers were instructed to respond to the letter by calling 888-345-5356, and decide on replacement or discounted new purchase.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- Issue #1: 4568 units; Issue#2: 5186 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2009-02-26
- Date posted
- 2009-06-23
- Date terminated
- 2012-03-07
- Location
- Beaverton, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JUMP START, MODEL 970300 (K021168) | Medical Research Laboratories, Inc. | 2002-06-26 |