Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use w...

FDA Device Recall #Z-0683-2018 — Class II — January 29, 2018

Recall Summary

Recall Number Z-0683-2018
Classification Class II — Moderate risk
Date Initiated January 29, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Electronics North America Corporation
Location Andover, MA
Product Type Devices
Quantity 28094 in total

Product Description

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).

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 Pattern

Worldwide Distribution - US Nationwide

Lot / Code Information

All QCPR meters and sensors in use with HeartStart MRx and FR3. MODEL #(s): 861444, 861332, 989803139951, 989803162401, 989803149941

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Z-0592-2019 Class II IntelliVue MX40 Patient Monitor, Model Nos. 865... Oct 10, 2018
Z-3227-2018 Class II Allura Xper F010, System Code 722003 Vascul... Jul 16, 2018
Z-3218-2018 Class II INTEGRIS SUITE, System Code 722199 Vascular... Jul 16, 2018
Z-3215-2018 Class II INTEGRIS CV, System Code 722030 Vascular, c... Jul 16, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.