Philips recalls HeartStart MRx devices using M3539A AC Power Module models M3535A through M3536M9. The AC power module may fail at a higher rate, causing device power loss or shock delivery issues if battery is not properly installed.
The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery.
Philips is recalling HeartStart MRx defibrillators that use specific AC power modules. The power modules may fail more often than expected, which could cause the device to lose power or fail to deliver shocks if the battery isn't installed correctly. This could be dangerous for patients needing emergency cardiac support.
The AC power module may fail more frequently than expected. If the battery isn't properly installed, the device could lose power and stop working. This might cause interruptions in monitoring or delays in delivering a shock or pacing, which could be critical for patients needing emergency cardiac support.
Owners of Philips HeartStart MRx defibrillators with the M3539A AC Power Module and specific model numbers (M3535A, M3536A, M3536M, M3536MC, M3536M2, etc.) are affected. Patients using these devices for cardiac monitoring are at risk of potential device failure.
Check if your HeartStart MRx device uses the M3539A AC Power Module. Look for model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, or other listed models. The device may have serial numbers starting with US00321116 or similar numbers from the provided list.
Identify your HeartStart MRx device model number and AC power module to see if it matches the recalled models listed in the notice.
Check if your device's serial number begins with any of the listed US00 numbers (e.g., US00321116, US00205647, etc.) to confirm it's affected.
The AC power module may fail at a higher rate than expected, which could cause the device to lose power or fail to deliver shocks if the battery isn't properly installed.
Check your device model and serial number against the list provided in the recall notice to see if it's affected. If it is, you should contact Philips for further instructions.
The device may not be safe to use as it could fail unexpectedly, leading to interruptions in monitoring or delays in delivering shocks.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1923-2019 — Philips Philips Hello, I own a Philips that is covered by recall Z-1923-2019 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.