Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL, Inc., A Welch A
FDA device recall Z-0918-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- MRL, Inc., A Welch Allyn Company
- Reason for recall
- A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED10 defibrillator.
- Action taken
- Urgent Medical Device Recall letters dated 4/26/04 were sent to the end users via certified mail on 4/26/04. The letters informed the users of the intemittent shock (fire or 3) button failure on the AED 10. The letters included a list of the affected serial numbers, and requested the users to call Welch Allyn MRL Technical Support as soon as possible at 1-800-462-0777 for a replacement AED 10 and to answer any questions. A replacement AED 10 will be sent to the end users within 10 days, and the users were requested to return their AED 10 in the same shipping box accompanying the replacement unit. A follow-up letter will accompany the replacement unit with instructions on how to verify the affected units, packing instructions for the return of the affected units to Welch Allyn MRL, and a correction response form to be completed and enclosed with the returned unit.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 460 units
- Distribution
- Nationwide, and internationally to the United Kingdom, Ireland, Singapore, France and South Africa.
- Date initiated
- 2004-04-26
- Date posted
- 2004-07-20
- Date terminated
- 2004-11-15
- Location
- Buffalo Grove, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JUMP START, MODEL 970300 (K021168) | Medical Research Laboratories, Inc. | 2002-06-26 |