Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufacture
FDA device recall Z-1106-06 · posted 2006-06-22 · Terminated
Recall details
- Recalling firm
- MRL, Inc., A Welch Allyn Company
- Reason for recall
- The Welch Allyn AED 20 Defibrillators 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 appropriate therapy.
- Action taken
- MRL issued a press release on 6/15/06, and began sending Urgent Medical Device Recall letters on the same date to the direct accounts informing them of the possibility of the defibrillator going into a terminal failure due to a U25 IC socket susceptible to defibrillation circuit board communication errors. The accounts were asked to respond to the notification witihin 5 working days by faxing or mailing the enclosed response form, or calling Welch Allyn-MRL Technical Support at 1-800-462-0777. A loaner AED 20 will then be sent to the consignee with instrucitons on how to return their unit for correction.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 580 units
- Distribution
- Worldwide-including USA, Australia, Canada, China, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Nicaragua, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, South Korea, Spain,
- Date initiated
- 2006-06-15
- Date posted
- 2006-06-22
- Date terminated
- 2007-07-19
- Location
- Buffalo Grove, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEDEFIBRILLATOR (K002232) | Medical Research Laboratories, Inc. | 2000-12-06 |