Recall Z-1106-06 ยท MKJ Automated External Defibrillators (Non-Wearable)
MRL, Inc., A Welch Allyn Company
Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part 972200
| Date | Jun 22, 2006 (initiated Jun 15, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 fo |
| Quantity | 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, Switzerland, United Arab Emirates and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002232 | AEDEFIBRILLATOR Medical Research Laboratories, Inc., Dec 6, 2000 |