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Lower risk Medical device recall · FDA · Published September 28, 2017

Philips HeartStart MRx Defibrillator Recall: EtCO2 Display Contamination Risk

Philips recalls 20 units of HeartStart MRx defibrillators due to potential EtCO2 module contamination causing inaccurate CO2 waveform displays. Affected units have specific serial numbers listed in the recall.

🇺🇸 FDA recall #Z-0278-2018Medical devicePhilips ›
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Recalling firmPhilips Electronics North America Corporation3000 Minuteman Rd · Andover, MA 01810-1032
✎ GovInfoNow plain-language explainer

What happened, in plain English

Philips is recalling 20 specific HeartStart MRx defibrillators because their EtCO2 module might be contaminated. This contamination could prevent the device from showing CO2 waveforms correctly, which is important for medical monitoring during emergencies. Read more at govinfonow.com/recall/72941-philips-heartstart-mrx-defibrillator-recall-etco2-display-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72941-philips-heartstart-mrx-defibrillator-recall-etco2-display-contamination-risk · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0278-2018

Cite this page

“Philips HeartStart MRx Defibrillator Recall: EtCO2 Display Contamination Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72941-philips-heartstart-mrx-defibrillator-recall-etco2-display-contamination-risk. Based on FDA recall #Z-0278-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0278-2018%22&limit=1).

Why it’s dangerous

The EtCO2 module in these defibrillators may contain contaminants that interfere with the device's ability to display CO2 waveforms. This could lead to inaccurate readings during critical medical situations where precise monitoring is needed.

Who’s affected

Healthcare professionals using the defibrillators for emergency cardiac care are most at risk. The recall affects only 20 specific units with unique serial numbers.

How to tell if you have this one

Check if your defibrillator has one of the 20 listed serial numbers: US00597060, US00597964, US00598048, US00598210, US00598784, US00599490, US00599495, US00599508, US00599572, US00599613, US00599615, US00599623, US00599726, US00600362, US00600363, US00600370, US00600422, US00600423, US00600438, US00600483.

  • Brand
    Philips
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Verify if your defibrillator has one of the 20 specific serial numbers listed in the recall.

How this recall unfolded

Recall timeline

FDA terminated this recall 12 months after the firm started it.

1. Firm started the recall: Sep 28, 201712. FDA classified it Class II: Dec 21, 201723. Published in FDA’s Enforcement Report: Dec 27, 201734. FDA terminated the recall: Oct 12, 2018420172018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0278-2018 (September 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0278-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA