Philips HeartStart MRx Defibrillator Recall: Defective Component May Prevent Shock
Philips recalls HeartStart MRx defibrillators (models M3535A & M3536A) due to a defective component that may prevent shock delivery in AED mode. Affected units have specific serial numbers.
Stop using this now
Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.
Contact the company
What happened, in plain English
Philips is recalling HeartStart MRx defibrillators with model numbers M3535A and M3536A because a defective component could prevent shock delivery in AED mode. This poses a serious risk to patients needing defibrillation during cardiac emergencies. Read more at govinfonow.com/recall/73435-philips-heartstart-mrx-defibrillator-recall-defective-component-may-prevent-shock.
Source Summary by GovInfoNow · govinfonow.com/recall/73435-philips-heartstart-mrx-defibrillator-recall-defective-component-may-prevent-shock · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0489-2018
Cite this page
“Philips HeartStart MRx Defibrillator Recall: Defective Component May Prevent Shock.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73435-philips-heartstart-mrx-defibrillator-recall-defective-component-may-prevent-shock. Based on FDA recall #Z-0489-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0489-2018%22&limit=1).
Why it’s dangerous
The defibrillator may have a defective component that fails to protect internal circuitry from high voltages during shock delivery. This defect could prevent the device from delivering necessary shocks in AED mode, potentially leading to fatal cardiac events.
Who’s affected
Healthcare professionals who use these defibrillators for cardiac emergencies are affected. Patients in cardiac distress could be at risk if the device fails to deliver shocks.
How to tell if you have this one
Check for model numbers M3535A or M3536A on the device. Affected units have specific serial numbers listed in the recall notice, including US00601802 through US00602377.
- Brand
Philips- Category
Medical device
What to do — step by step
Stop Using It Now
Immediately stop using the defibrillator if it is affected by the recall. The device may not deliver shocks in AED mode, which could be life-threatening.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
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-0489-2018 (July 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0489-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 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.