Physio-Control, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1143-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.)

Product Classification:

Class II

Date Initiated: January 16, 2017

Date Posted: February 15, 2017

Recall Number: Z-1143-2017

Event ID: 76162

Reason for Recall:

The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.

Status: Terminated

Product Quantity: 7 units in the US and 13 modules worldwide (5 international; and 8 owned by Physio)

Code Information:

LOT NUMBERS OF AFFECTED MODULE: Lot # 1520 and 1544. SERIAL NUMBERS OF DEVICES: 32877820, 34356891, 35984435, 37223110, 37440401, 37456675, and 37913307.

Distribution Pattern:

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 GUIANA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LITHUANIA, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM.

Voluntary or Mandated:

Voluntary: Firm initiated