The Recall Desk

FDA (Devices) recall action 76162

Physio-Control, Inc. recalled 2 products on 2017-02-15

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-02-15
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2017-02-15

    Physio-Control Recalls LIFEPAK 12 Defibrillators with Erratic CO2 Readings

    Physio-Control is recalling LIFEPAK 12 Defibrillators because the End-Tidal CO2 reading may intermittently display an invalid value of XXX during operation.

    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
    Category
    Distribution
    6 states
  • HighFDA (Devices)··2017-02-15

    Physio-Control Recalls LIFEPAK 15 Defibrillators with Erroneous CO2 Readings

    Physio-Control is recalling LIFEPAK 15 Monitor/Defibrillators with End-Tidal CO2 options because the CO2 reading may intermittently display an incorrect value of XXX.

    Product
    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.
    Category
    Distribution
    6 states