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Model note · Defibrillator

Philips HeartStart MRx monitor/defibrillator

The HeartStart MRx is a portable biphasic monitor and defibrillator offering AED, manual defibrillation, synchronised cardioversion and pacing, with optional SpO2, NBP, EtCO2, invasive pressure, temperature, 12 lead ECG and Q-CPR feedback. It is no longer sold new but remains widely installed in hospitals and ambulances, and its long recall history makes field action tracking a core part of looking after it.

The model

Maker, model and type.

Maker
Philips Medical Systems
Model
HeartStart MRx monitor/defibrillator (M3535A hospital, M3536A pre hospital)
Device type
Defibrillator
Main document
Open the public document

Key specifications

What the public record says.

ItemValueSource
WaveformBiphasic truncated exponential, parameters adjusted for patient impedanceSource
Manual energy settings1 to 10, 15, 20, 30, 50, 70, 100, 120, 150, 170, 200 J; limited to 50 J with internal paddlesSource
Delivered energy accuracyPlus or minus 2 J up to 10 J, plus or minus 15% from 15 J upwardsSource
Charge time to 200 JUnder 5 s with a new full battery at 25 degrees C; under 15 s on the M3539A AC module aloneSource
Patient impedance range25 ohm minimum external, 15 ohm minimum internal, 180 ohm maximumSource
Battery (M3538A lithium ion)Under 0.82 kg, about 3 h to full charge (2 h to 80%), at least 50 charge and shock cycles at 200 JSource
Battery run timeAt least 5 h full monitoring with 20 shocks at 200 J; at least 9 h ECG onlySource
Size and weight31.5 x 21.0 x 29.5 cm with pads; 13.9 lb or less with pads, cable, battery and paperSource
Network connectivityIntelliVue Network connection added under K062233Source

Recalls

Known FDA recalls.

  • Z-2794-20202020-07-16

    Therapy switch failure could block the selected function or deliver a different energy.

    FDA record
  • Z-1499-20202020-02-26

    Dropped units could have hidden internal damage and fail to deliver therapy.

    FDA record
  • Z-1923-20192019-06-07

    M3539A AC power module failing at higher than expected rate.

    FDA record
  • Z-0603-20192018-11-23

    M3538A batteries with a defective thermal cut off could stop charging or supplying power.

    FDA record
  • Z-2035-20182018-05-03

    Wrong component on therapy PCB could cause failure to charge.

    FDA record
  • Z-2842-20162016-08-26

    Handle could separate from the housing after rear case mount breakage.

    FDA record
  • Z-1797-20132013-06-19

    Possible unsynchronised cardioversion shock.

    FDA record
  • Z-2347-20122012-06-20

    Therapy cable connection wear affecting pads and paddles cable detection.

    FDA record

Safety

Safety warnings from the record.

  • Only qualified service personnel should service or repair the device; detailed repair data is in the separate service manual. Source
  • A 2013 recall found the MRx could deliver an unsynchronised cardioversion shock, which may induce VF, so software must be at the corrected level. Source
  • Units on battery only may shut down without warning under strong RF interference unless corrected. Source
  • Wrong wiring of the vehicle wall mount DC power module during installation can cause smoke or fire. Source

Sources

Where this note comes from.

Not covered: Specs and messages come from one public edition of the IFU; earlier software versions may behave differently. The MRx service manual was not read, so service codes, Operational Check failure codes and part numbers are not given. There are over 50 recall records; only the most relevant are listed, and many were driven by a 2017 consent decree period. The manufacturerUrl points to the public IFU rather than a product page, as the MRx is discontinued. MAUDE counts include bulk reporting and are not failure rates.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.