Recall Z-0129-2008 ยท MKJ Automated External Defibrillators (Non-Wearable)
Welch Allyn Protocol, Inc
Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers: 970302E,970308E,970309E, 970310E and 970311E;
| Date | Nov 6, 2007 (initiated Oct 26, 2007) |
| Status | Terminated |
| Reason | Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient |
| Root cause | Nonconforming Material/Component |
| Action | The firm issued a press release on 10/30/07, and has set up a call center for customers, and plans to send three (3) certified mailings to notify affected customers, alert them of the issue, and provide instructions on how to return their device. The first letter dated 10/26/07 was sent via certified mail to customers on 10/26/07. The letter informs customers of the firm recalling the product to correct faulty capacitors on the circuit board, and which could result in a malfunction that prevents or delays delivery of a defibrillating shock. The letter indicates the faulty AED10 devices were |
| Quantity | 1,794 distributed - 1176 in US and 618 internationally |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021168 | JUMP START, MODEL 970300 Medical Research Laboratories, Inc., Jun 26, 2002 |