Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufacture
FDA device recall Z-0806-05 · posted 2005-05-12 · Terminated
Recall details
- Recalling firm
- MRL, Inc., A Welch Allyn Company
- Reason for recall
- The Welch Allyn AED 20 product may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropiate therapy.
- Action taken
- Urgent Medical Device Recall letters dated 04/28/2005 were sent to the direct accounts informing them of the possibility in a terminal failure due to the radio frequency interference generated inside the AED 20 resulting from an intermittent electrical short. Any questions were directed to Welch Allyn-MRL Technical Support at 1-800-462-0777.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 597
- Distribution
- Nationwide and internationally to Australia, Canada, China, France, Germany, Ireland, Israel, Malaysia, the Middle East, New Zealand, the Philippines, Poland, Singapore, South America, South Korea, Sw
- Date initiated
- 2005-04-28
- Date posted
- 2005-05-12
- Date terminated
- 2006-09-01
- Location
- Buffalo Grove, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEDEFIBRILLATOR (K002232) | Medical Research Laboratories, Inc. | 2000-12-06 |