Recall Z-1144-2017 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions.
| Date | Jan 16, 2017 |
| Status | Terminated |
| Reason | The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. |
| Root cause | Process control |
| Action | Physio Control sent the Urgent Medical Device Correction LIFEPAK 15 Monitor/ Defibrillator and LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 (EtCO2) option letter, dated January 2017, and confirmation sheets to consignees on January 16, 2017. Physio-Control is contacting customers with affected devices to schedule the correction of their device(s), which will include replacing the EtCO2 module. Required Customer Actions: 1. Please forward this information to all affected sites, trainers and users that may have affected LIFEPAK 12 or LIFEPAK 15 device(s). 2. Consignees should follow t |
| Quantity | 2584 units total (1501 units in the US; 1034 units international; and 49 units owned by Physio). 50 modules total |
| Distribution | Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIAN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142430 | LIFEPAK 15 monitor/defibrillator Physio-Control, Inc., Dec 19, 2014 |