Recall Z-1722-2011 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio Control, Inc.
The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx, 3202488-000, U3202487-000, 3202488-015, and U3202488-000. The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e are acute cardiac care devices used by authorized healthcare providers in hospital and clinic settings. It is commonly found on "code" or "crash" cars in hospital hallways, plugged into AC power. In
| Date | Mar 18, 2011 (initiated May 27, 2010) |
| Status | Terminated |
| Reason | A component failure on the AC power supply assembly results in "NO AC POWER" operation. A failure of AC power can result in a delay of defibrillation therapy if backup battery power is depleted. |
| Root cause | Device Design |
| Action | PhysioControl, Inc. began sending an Urgent Medical Device Correction letter via certified receipt to all affected customers describing the potential issue. Customers were advised to keep the defibrillators in service and to follow the daily Operator's Checklist. All power supplies will be updated. For questions customers were instructed to contact Technical Support at 1-800-442-1142. For questions regarding this recall call 425-867-4000. |
| Quantity | 53550 units |
| Distribution | Worldwide distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MI, MD, MI, NC, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY and the coutnries of ANGUILLA, ARGENTINA, AUSTRALIA, BAHAMAS, BAHRAIN, BARBADOS, BOLIVIA, BRAZIL, CAYMAN ISLANDS, |
| FDA record | Open on fda.gov |