510(k) K063375 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEARTSTART MRX, MODELS M3535A OR M3536A
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Jan 11, 2007 |
| Received | Nov 8, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063375
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2020 | Philips North America, LLC HeartStart MRx Processor Board PCA Replacement Kits
453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital sett Terminated |
MKJ | None listed |
| Feb 26, 2020 | Philips North America, LLC HeartStart MRx Monitor/Defibrillators with model numbers M3535A
M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5,
M3536M6, M3536M7, M3536M8, and M3536M9. Terminated |
MKJ | None listed |
| Jan 14, 2020 | Philips North America, LLC Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments. Terminated |
MKJ | None listed |
| Jul 16, 2019 | Philips North America, LLC HeartStart MRx Monitor/Defibrillator
Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mo Terminated |
MKJ | None listed |
| Jul 5, 2019 | Philips North America, LLC Philips HeartStart MRx devices in use with the M3539A AC Power Module:
M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 Terminated |
MKJ | None listed |
| May 3, 2018 | Philips Electronics North America Corporation HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289)
Product Automated external defibrillators (non-wearable)
Product Usage:
The HeartStart MRx is for use for the termina Terminated |
MKJ | None listed |
| Sep 28, 2017 | Philips Electronics North America Corporation Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator Terminated |
MSX | 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 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.