510(k) K051134 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
| Applicant | Philips Medical Systems, North Attleboro MA, US |
| Decision | Substantially Equivalent, Sep 8, 2005 |
| Received | May 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051134
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2020 | Philips North America, LLC Philips HeartStart MRx Monitor/Defibrillators
Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation. Terminated |
MKJ | None listed |
| Nov 23, 2018 | Philips North America LLC HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators. Terminated |
MKJ | None listed |
| Feb 22, 2018 | Philips Electronics North America Corporation Philips QCPR Meter - used with MRx
Product Usage:
The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on Terminated |
LIX | None listed |
| Feb 8, 2018 | Philips North America, LLC MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969
Product Usage:
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. T Terminated |
MKJ | None listed |
| Sep 28, 2017 | Philips Electronics North America Corporation Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator Terminated |
MSX | None listed |
| Jul 17, 2017 | Philips Electronics North America Corporation ECG Out Cable - Heartstart MRx
M1783A/M5526A 12-pin Sync cables
All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641.
Manufactured - Septembe Terminated |
MKJ | None listed |
| Mar 24, 2017 | Philips North America, LLC HeartStart MRx Monitor/Defibrillator,
Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 Terminated |
MKJ | None listed |
| Aug 26, 2016 | Philips Electronics North America Corporation HeartStart MRx Monitor/Defibrillator
Models: M3535A and M3536A Terminated |
MKJ | None listed |
| Apr 14, 2016 | Philips Electronics North America Corporation HeartStart MRx Monitor/Defibrillator
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel tra Terminated |
MKJ | None listed |
| Nov 20, 2015 | Philips Electronics North America Corporation Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6.
For use for the termination of ventricular tachycardia and ventricular fibr Terminated |
MKJ | None listed |
| Nov 13, 2015 | Philips Electronics North America Corporation ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart Terminated |
MKJ | None listed |
| Nov 10, 2015 | Philips Medical Systems, Inc. Philips HeartStart MRx Monitor/Defibrillator
Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibri Terminated |
MKJ | None listed |
| Nov 5, 2015 | Philips Medical Systems, Inc. HeartStart MRx monitor/defibrillator
Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6
Product Usage:
The HeartStart MRx is for use for the termination of ventricular Terminated |
MKJ | None listed |
| Nov 3, 2015 | Philips Medical Systems, Inc. Philips HeartStart MRx Monitor/Defibrillators
Models: M3535A and M3536A Terminated |
MKJ | None listed |
| Jan 13, 2015 | Philips Medical Systems, Inc. HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6
Product Usage: The HeartStart MRx is for use for the termination of v Terminated |
MKJ | None listed |
| Mar 12, 2014 | Philips Medical Systems, Inc. Philips HeartStart MRx Monitor/Defibrillator
Models: M3535A and M3536A with Q-CPR Meter Option B08
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrill Terminated |
MKJ | None listed |
| Feb 26, 2014 | Philips Medical Systems, Inc. Philips HeartStart MRx Monitor/Defibrillator used
Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC Terminated |
MKJ | None listed |
| Feb 26, 2014 | Philips Medical Systems, Inc. HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries
Revision J
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is f Terminated |
MKJ | None listed |
| Feb 26, 2014 | Philips Medical Systems, Inc. M3536A HeartStart MRx with Wireless Link Upgrade (861289)
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified Terminated |
MKJ | None listed |
| Feb 26, 2014 | Philips Medical Systems, Inc. Philips HeartStart XL, Defibrillator/Monitor
Model number M4735A
Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in t Terminated |
MKJ | None listed |
| Feb 26, 2014 | Philips Medical Systems, Inc. Philips HeartStart MRx Monitor/Defibrillator; Models:
M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC.
Used for the termination of ventricular tachycardia and ventricular fibrillation. Terminated |
MKJ | None listed |
| Feb 25, 2014 | Philips Medical Systems, Inc. HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricula Terminated |
MKJ | None listed |
| Dec 31, 2013 | Philips Medical Systems, Inc. Philips HeartStart MRx Monitor/Defibrillator
Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6
The HeartStart MRx is for use for the termination of ventricular tachycardia an Terminated |
MKJ | None listed |
| Dec 27, 2013 | Philips Medical Systems, Inc. Philips HeartStart MRx Monitor/Defibrillator
Models: M3536A Options A20 - A27, HeartStart MRx ALS
Monitor (Grey)
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventr Terminated |
MKJ | None listed |
| Dec 24, 2013 | Philips Medical Systems, Inc. Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for u Terminated |
MKJ | None listed |
| Jul 24, 2013 | Philips Healthcare Inc. Philips HeartStart MRx Monitor/Defibrillator,
Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6
The device is for use by qualified medical personnel trained i Terminated |
MKJ | None listed |
| Apr 29, 2013 | Philips Healthcare Inc. HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6.
The HeartStart MRx is for use for the termination of ventricular tachycardi Terminated |
MKJ | None listed |
| Sep 10, 2012 | Philips Healthcare Inc. Philips HeartStart MRx monitor/defibrillators
Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6
The Heartstart MRx is for use for the terminatio Terminated |
MKJ | None listed |
| Jul 11, 2012 | Philips Healthcare Inc. Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03
The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for Terminated |
MKJ | None listed |
| Jun 27, 2012 | Philips Healthcare Inc. Philips HeartStart MRx monitor/defibrillators
Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6
Product Usage:
The Heartstart MRx is for use for the termination of ventricular tachycardia and ven Terminated |
MKJ | None listed |
| Mar 8, 2011 | Philips Healthcare Inc. Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp.
Used for the termination Terminated |
MKJ | None listed |
| Aug 27, 2010 | Philips Healthcare Inc. HeartStart MRx Defibrillator/Monitor with Q-CPR
Meter option.The HeartStart MRx monitor/defibrillator has an option (Q-CPR Meter) to provide visual and audible feedback to the rescuer on the quality Terminated |
MKJ | None listed |
| May 24, 2010 | Philips Healthcare Inc. HeartStart MRx Defibrillator Monitor, Model M3535A
HeartStart MRx Defibrillator Monitor, Model M3536A
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibr Terminated |
MKJ | None listed |
| Apr 9, 2010 | Philips Healthcare Inc. HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips 14.8-Volt Lithium Ion Battery (ModeI M3538A).
The HeartStart MRx is for use for the termination of ventricula Terminated |
MKJ | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. AC power cords manufactured by Electri-Cord with tall bridge design. Used across all Philips product lines, as well as Respironics/Philips products, Dixtel owned products and Dixtal (formerly Novamet Terminated |
MKJ | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. HeartStart MRx Defibrillator/Monitor.
For use for the termination of ventricular tachycardia and ventricular fibrillation. Terminated |
MKJ | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. HeartStart MRx- AC power module kit.
For use for the termination of ventricular tachycardia and ventricular fibrillation. Terminated |
MKJ | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. DeviceLink Connectivity Hardware.
Supports Philips specified manufacturers' devices including urimeters, ventilators, oximeters, patient monitors, infusion pumps and anesthesia machines. Terminated |
MWI | None listed |
| Dec 23, 2009 | Philips Healthcare Inc. Philips HeartStart Vehicle Wall Mount, Model M5528A
with Philips HeartStart DC Power Module, Model M5529A.
The HeartStart MRx portable external defibrillator has optional accessories which include Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.