CLASS II Device recall · Reported 28 Feb 2018 · FDA Enforcement Report
Philips QCPR Meter - used with FR3 recalled by Philips Electronics North
Philips Electronics North America is recalling Philips QCPR Meter - used with FR3, distributed nationwide in the US. The recall was initiated on 29 Jan 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0683-2018
- FDA event ID
- 79016
- Recalling firm
- Philips Electronics North America, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jan 2018
- FDA classified
- 22 Feb 2018
- Reported
- 28 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 29 Jan 2018 | Recall initiated by company | |
| 22 Feb 2018 | Classified by FDA | +24 days |
| 28 Feb 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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).
Where it was distributed
Worldwide Distribution - US Nationwide
Questions about this recall
Is Philips QCPR Meter - used with FR3 recalled?
Yes. Philips Electronics North America recalled Philips QCPR Meter - used with FR3 on 29 Jan 2018. The recall is Class II and its status is Terminated. Recall number Z-0683-2018.
Why was it 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
Which lots are affected?
All QCPR meters and sensors in use with HeartStart MRx and FR3. MODEL #(s): 861444, 861332, 989803139951, 989803162401, 989803149941
Where was it sold?
Worldwide Distribution - US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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