Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is Recalled by Physio-Control, Inc. Due to The End-Tidal CO2 (EtCO2) reading can intermittently show...

Date: January 16, 2017
Company: Physio-Control, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Physio-Control, Inc. directly.

Affected Products

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.)

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

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Physio-Control, Inc.

Physio-Control, Inc. has 38 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report