Recall Z-1143-2017 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
| 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 | 7 units in the US and 13 modules worldwide (5 international; and 8 owned by Physio) |
| 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
| K102972 | LIFEPAK 12 Physio-Control, Inc., Dec 22, 2010 |