Recall Z-2488-2019— Philips North America, LLC

Name: FDA recall Z-2488-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-16

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2019-07-16, terminated 2022-10-20. It names one FDA 510(k) clearance: K063375. Product: 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 mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS). Manual operation allows users to select energy levels for external and internal defibrillation. Users may also perform synchronized cardioversion. Non-invasive external pacing is a device option. In AED mode, the HeartStart MRx allows the provider who is trained in Basic Life Support (BLS) to provide defibrillation therapy. The device analyzes a patient s rhythm and advises the user to deliver a shock. Voice prompts guide the user through the defibrillation process by providing instructions and patient information. The voice prompts are reinforced by messages that appear on the display. In both modes of operation, the HeartStart MRx utilizes impedance compensating biphasic truncated exponential therapy waveform. The HeartStart MRx can also be used for ECG monitoring of a patient using 3, 5 or 12 lead cables.. Reason: Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-07-16
Terminated: 2022-10-20
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K063375 — HEARTSTART MRX, MODELS M3535A OR M3536APhilips Medical Systems·cleared 2007-01-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS). Manual operation allows users to select energy levels for external and internal defibrillation. Users may also perform synchronized cardioversion. Non-invasive external pacing is a device option. In AED mode, the HeartStart MRx allows the provider who is trained in Basic Life Support (BLS) to provide defibrillation therapy. The device analyzes a patient s rhythm and advises the user to deliver a shock. Voice prompts guide the user through the defibrillation process by providing instructions and patient information. The voice prompts are reinforced by messages that appear on the display. In both modes of operation, the HeartStart MRx utilizes impedance compensating biphasic truncated exponential therapy waveform. The HeartStart MRx can also be used for ECG monitoring of a patient using 3, 5 or 12 lead cables.

Reason for recall

Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices.

Data sourced from openFDA. This site is unofficial and independent of the FDA.