The Recall Desk

FDA (Devices) recall action 84425

Physio-Control, Inc. recalled 2 products on 2020-01-22

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
2020-01-22
Critical
0
Units
30,657

Why these products were recalled

Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.

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.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-01-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Keypad Oxidation

    Physio-Control is recalling 29,952 LIFEPAK 15 Monitor/Defibrillators worldwide because oxidation on the keypad may prevent the device from delivering a shock.

    Product
    LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
    Category
    Distribution
    52 states