Recall Z-0294-2018 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response throughout a hospital.
| Date | Jan 11, 2018 (initiated Dec 4, 2017) |
| Status | Terminated |
| Reason | Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death. |
| Root cause | Other |
| Action | The recall was initiated by letter on 12/04/2017. The recall notice stated: "Physio-Control s Planned Actions Physio-Control will contact customers with LIFEPAK 20e devices who are potentially affected to arrange for a device correction. This correction will include the replacement of the Power PCBA. Required Customer Actions 1. Please forward this letter to all of your sites, trainers, and users that have an affected LIFEPAK 20e device(s) as identified on the attached Confirmation Sheet. 2. Promptly return the completed Confirmation Sheet to Physio-Control. 3. Follow the recommended daily O |
| Quantity | 3831 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130454 | LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR Physio-Control, Inc., Aug 21, 2013 |