The Recall Desk

FDA (Devices) recall action 81939

Physio-Control Inc recalled 2 products on 2019-03-06

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
2019-03-06
Critical
0
Units
13,687

Why these products were recalled

Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Devices)··2019-03-06

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillator Service Kits

    Physio-Control is recalling 682 LIFEPAK 15 Monitor/Defibrillator service kits because they may lock up after delivering a shock, leaving the monitor display blank.

    Product
    LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-03-06

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Lockup Condition

    Physio-Control is recalling 13,005 LIFEPAK 15 Monitor/Defibrillators because they may lock up after delivering a shock, leaving the display blank and unresponsive.

    Product
    LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator…
    Category
    Distribution
    0 states