510(k) · Cleared
Recalled · Class I · 2017Heartstart MRX Monitor/Defibrillator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Nov 22, 2006 as substantially equivalent to K031187 (Philips Medical Systems, 2003) and 1 other predicate after a 112-day review. Its family tree reaches back 1 generation to 2003. 3 of the 3 devices in its family, counting itself, have a Class I recall. It has been recalled 11 times, including 2 Class I recalls.
- Decided
- Nov 22, 2006
- Review
- 112 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 11 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K031187 (2003). 2 ancestors in all. No later device cites it as a predicate yet. 3 of the 3 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK031187 Heartstart MRX, Model M3535APhilips Medical Systems · 2003 · Recalled (Class I)
- This deviceK062233 Heartstart MRX Monitor/DefibrillatorPhilips Medical Systems North America, Inc. · 2006
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031187 | Heartstart MRX, Model M3535A | Philips Medical Systems | 2003 | Class I |
| 0 (this device) | K062233 | Heartstart MRX Monitor/Defibrillator | Philips Medical Systems North America, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031187 | Heartstart MRX, Model M3535ASummary page 1…Cardiopulmonary Resuscitation Aid 3. The new device is substantially equivalent to the previously cleared HeartStart MRx Monitor/Defibrillator software cleared under K031187 and K051134. 4. The modification is a change that provides network connectivity via the Philips IntelliVue Network. 5. Th… | 2003 |
| * | K051134 | Heartstart MRX with Q-CPR Option, Models M3535A or M3536ASummary page 1…Resuscitation Aid 3. The new device is substantially equivalent to the previously cleared HeartStart MRx Monitor/Defibrillator software cleared under K031187 and K051134. 4. The modification is a change that provides network connectivity via the Philips IntelliVue Network. 5. The new device ha… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 28, 2017 | Class II | Z-0278-2018 | Nonconforming Material/Component | Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram). |
| Jul 17, 2017 | Class II | Z-0348-2018 | Device Design | Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/defibrillator experiences interference… |
| Jul 12, 2017 | Class I | Z-0489-2018 | Nonconforming Material/Component | 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. |
| Feb 24, 2017 | Class I | Z-1417-2017 | Device Design | HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring |
| Aug 26, 2016 | Class II | Z-2842-2016 | Device Design | The handle can separate from the MRx housing due to breakage of mounts on the rear case. |
| Apr 14, 2016 | Class II | Z-1612-2016 | Employee error | MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. |
| Oct 14, 2015 | Class II | Z-0320-2016 | Software design | The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when… |
| Dec 23, 2014 | Class II | Z-0219-2016 | Software design | MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed |
| Nov 19, 2014 | Class II | Z-0204-2016 | Process control | 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a… |
| Nov 19, 2014 | Class II | Z-0262-2016 | Device Design | MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, making it inaccessible. 2. The handle… |
| Nov 19, 2014 | Class II | Z-0963-2015 | Software design | Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently. |
The 5 latest of 11 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K051134Heartstart MRX with Q-CPR Option, Models M3535A or M3536APhilips Medical Systems · 2005 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 12 Class I recalls
- K031187Heartstart MRX, Model M3535APhilips Medical Systems · 2003 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
- 3 other devices also cite its predicate K031187.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. AED Therapy To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that…
Read the full statement (300 words)
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
AED Therapy
To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.
Manual Defibrillation
Asynchronous defibrillation is the initial treatment for ventricularfibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous dlefibrillation is indicated for termination of atrial fibrillation.
Non-invasive External Pacing Therapy
The pacing option is intended for treating patients with symptomatic bradycardia. Itcan also be helpful in patients with asystole, if performed early.
Pulse Oximetry
The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level.
Non-invasive Blood Pressure Monitoring
The NBP option is intended for non-invasive measurement of a patient's arterial blood pressure.
End-tidal C02
The EtCO2 option is intended for non-invasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.
12-Lead ECG
The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.
Q-CPR
The Q-CPRTM option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).
The Q-CPR option is contraindicated as folldws:
- The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less that 25 kg).
- The Q-CPR option is not for use when CPR is contraindicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062233 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062233: Heartstart MRX Monitor/Defibrillator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062233
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026