Philips recalls HeartStart MRx defibrillators (models M3535A-M3536M9) due to potential therapy switch failure causing delayed or failed shocks. Affected devices may not deliver intended therapy during cardiac emergencies.
The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user. These device behaviors could result in a delay in therapy or a failure to deliver the intended therapy.
Philips is recalling HeartStart MRx defibrillators with specific model numbers because the therapy switch might fail. This could mean the device doesn't perform the selected function, changes energy settings incorrectly, or delivers shocks at the wrong energy level. If this happens during a cardiac emergency, it might delay or prevent life-saving treatment.
The therapy switch could malfunction, causing the device to either not perform the selected function, fail to change energy settings, or deliver shocks at an incorrect energy level. This might delay or prevent life-saving treatment during cardiac emergencies.
Healthcare professionals using these defibrillators in hospitals or emergency settings are most at risk. The recall affects all units sold with model numbers M3535A through M3536M9.
Check the model number on the device label. Affected models are M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9. All devices produced for hospital and emergency use are affected.
Look for the model number on the device label to confirm if it's affected (M3535A through M3536M9).
Reach out to Philips customer support for guidance on next steps.
The therapy switch may fail, causing the device to not perform selected functions, change energy settings incorrectly, or deliver shocks at the wrong energy level, which could delay or prevent life-saving treatment.
Yes, all models from M3535A to M3536M9 are affected.
No, but healthcare professionals should check the model number and contact Philips for guidance.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2794-2020 — Philips Philips Hello, I own a Philips that is covered by recall Z-2794-2020 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.
