510(k) K061707 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Aug 11, 2006 |
| Received | Jun 16, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K061707
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.