The Recall Desk

FDA (Devices) recall action 79016

Philips Electronics North America Corporation recalled 2 products on 2018-02-28

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
2018-02-28
Critical
0
Units
56,188

Why these products were recalled

Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent Injunction No. 1:17-cv-11955-DJC, entered October 31, 2017 between United States of America and Philips North America

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

  • ModerateFDA (Devices)··2018-02-28

    Philips QCPR Meter Recall for CPR Feedback and Injury Information

    Philips is recalling QCPR meters used with HeartStart defibrillators to inform users of correct pad placement and CPR-related injuries.

    Product
    Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-02-28

    Philips QCPR Meter Recall for CPR Instruction and Injury Information

    Philips is recalling QCPR meters to inform users of correct pad placement and injuries associated with CPR performance.

    Product
    Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02…
    Category
    Distribution
    0 states