Philips Electronics North America Corporation: Philips QCPR Meter - used with FR3 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 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 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 company is also informing users about injuries that can be associated with proper performance of CPR. This notification affects approximately 28,094 QCPR meters and sensors worldwide that are used with HeartStart MRx and FR3 devices, including model numbers 861444, 861332, 989803139951, 989803162401, and 989803149941.

This notification is required under a Consent Decree of Permanent Injunction entered in federal court on October 31, 2017. The source document does not specify a remedy or what action affected consumers should take.

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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