Recall Z-1143-2017— Physio-Control, Inc.

Name: FDA recall Z-1143-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-16

Class II · Terminated

Class II FDA medical device recall by Physio-Control, Inc., initiated 2017-01-16, terminated 2018-09-11. It names one FDA 510(k) clearance: K102972. Product: 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.). Reason: The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation..

Recalling firm: Physio-Control, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-01-16
Terminated: 2018-09-11
Firm location: Redmond, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K102972 — LIFEPAK 12Physio-Control, Inc.·cleared 2010-12-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.)

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.