Philips recalls HeartStart MRx Defibrillators with specific model numbers due to risk of device failure after being dropped or hit, potentially leading to patient death.
Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a severe mechanical shock, even though the device did not have visible external damage or the Ready for Use ( RFU ) indicator on the unit did not immediately indicate a problem. One of these reports involved a death of a patient who could not be resuscitated.
Philips is recalling HeartStart MRx Defibrillators with model numbers M3535A through M3536M9. The devices can fail to deliver therapy after being dropped or subjected to severe shock, even without visible damage, which has led to one patient death.
The defibrillators can suffer internal damage from drops or severe impacts, even when there's no visible damage or the Ready for Use indicator shows normal function. This damage can prevent the device from delivering necessary therapy during critical cardiac emergencies, potentially causing patient death.
Healthcare providers using these defibrillators for cardiac emergencies are most at risk. Patients receiving treatment with the recalled devices could face life-threatening situations if the device fails during use.
Check for model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2 through M3536M9 on the device. All units produced by Philips North America are affected by this recall.
Identify the model number on the defibrillator to confirm if it is in the affected list (M3535A through M3536M9).
Reach out to Philips customer support for guidance on next steps if the device is affected.
Philips has received reports of HeartStart MRx Defibrillators failing to deliver therapy after being dropped or subjected to severe mechanical shock, even without visible damage or a malfunctioning Ready for Use indicator. One report involved a patient death.
The recall record does not specify a remedy, so no immediate fix is provided. Affected users should contact Philips for guidance.
Check the model number on the device; affected units have model numbers M3535A through M3536M9. All units produced by Philips North America are affected.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1499-2020 — Philips Philips Hello, I own a Philips that is covered by recall Z-1499-2020 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
