The Recall Desk

FDA (Devices) recall action 86441

Philips North America, LLC recalled 2 products on 2020-11-04

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
2020-11-04
Critical
0
Units
11,144

Why these products were recalled

The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that includes a test for the switched paddles only, which will detect this failure mode.

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

  • HighFDA (Devices)··2020-11-04

    Philips Recalls Sterilizable Defibrillator Paddles Due to Undetected Failure Mode

    Philips is recalling 2,202 sterilizable defibrillator paddles because standard periodic checks may fail to detect a specific failure mode in switchless internal models.

    Product
    Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent p
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-11-04

    Philips Recalls Sterilizable Defibrillator Paddles Due to Undetected Failure Mode

    Philips is recalling 8,942 sterilizable defibrillator paddles because standard checks may miss a specific failure mode. An updated test procedure is available to detect the issue.

    Product
    Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent pat
    Category
    Distribution
    0 states