Philips Electronics North America Corporation: Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrilla

Is my product affected?

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 installed. The Q-CPR option prov

• UPC 989803139951
• UPC 989803162401
• UPC 989803149941

Check against the official notice below — it lists the full affected range.

What happened

Philips Electronics North America Corporation is informing users about the correct placement of the disposable adhesive pad on the Philips QCPR meter, which is used with the Philips HeartStart FR3 automated external defibrillator. The recall also addresses injuries associated with proper performance of CPR. The affected product includes all QCPR meters and sensors in use with HeartStart MRx and FR3 devices, with model numbers 861444, 861332, 989803139951, 989803162401, and 989803149941. A total of 28,094 units were distributed worldwide and throughout the United States.

This action is required under a Consent Decree of Permanent Injunction entered on October 31, 2017. The recall notice does not specify a remedy or course of action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: 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 Distribution: Worldwide Distribution - US Nationwide Quantity: 28094 in total Lot/code info: All QCPR meters and sensors in use with HeartStart MRx and FR3. MODEL #(s): 861444, 861332, 989803139951, 989803162401, 989803149941

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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