Philips Electronics North America Corporation recalls Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart…

Recall date

January 29, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0683-2018

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

Worldwide Distribution - US Nationwide

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).