Recall Z-1223-2007 ยท MKJ Automated External Defibrillators (Non-Wearable)
Welch Allyn Protocol, Inc
Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E)
| Date | Sep 19, 2007 (initiated Aug 23, 2007) |
| Status | Terminated |
| Reason | Failure to deliver therapy: The Welch Allyn AED20 Defibrillators may display a "Defib Comm" error message on the device display during use which may result in failure of the device to analyze the patient's ECG and deliver the appropriate therapy. |
| Root cause | Process control |
| Action | On 8/23/07 the firm sent a press release to the Associated Press for release. On 8/29/07 the firm began sending URGENT MEDICAL DEVICE RECALL letters to their consignees informing them of the possibility of the defibrillator to fail to resuscitate the patient. The accounts were asked to respond to the notification within 5 working days by faxing or mailing an enclosed response. End users will be provided with a loaner device while their unit is being serviced. Distributors were sent a separate letter request they provide their customer names to the firm so that the firm can send letters to |
| Quantity | 1,637 devices |
| Distribution | Worldwide to include USA, Australia, New Zealand, South Africa, China, Hong Kong, Taiwan, Malaysia, Singapore, Phillippines, South Korea, Viet Nam, Egypt, France, Germany, Ireland, India, Israel, Pakistan, Poland, Russia, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom, Canada, Ecuad |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002232 | AEDEFIBRILLATOR Medical Research Laboratories, Inc., Dec 6, 2000 |