News | Defibrillator Monitors | March 28, 2017

Philips Healthcare Recalls HeartStart MRx Monitor/Defibrillator

Class I recall initiated due to electrical issues that may prevent the device from operating properly

Philips, FDA, class I recall, HeartStart MRx Monitor/Defibrillator

March 28, 2017 — Philips and the U.S. Food and Drug Administration (FDA) announced the company has initiated a recall of its HeartStart MRx Monitor/Defibrillator. The Class I recall is due to electrical and battery connection issues that may prevent the device from powering up, charging and delivering electrical shock therapy. The device may also unexpectedly stop pacing. A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury or death.

The HeartStart MRx Monitor/Defibrillator is used to pace people with a slow heart beat or to deliver lifesaving electrical shocks to people with sudden cardiac arrest. Electrodes are attached to the patient and then connected to the device to help it analyze a patient's heart rhythm. The electrodes deliver an electrical shock to restore a normal heart rhythm during sudden cardiac arrest, or to pace the heart at a normal rate when it slows down. The HeartStart MRx Monitor/Defibrillator is intended for use by medical professionals who are trained in CPR.

Philips sent an “Urgent Medical Device Correction” notice to its customers in February. The company said the cause of the issue can be easily verified by:

  • Identifying affected devices in their possession using the model number information;
  • Inspecting that the battery connector pins are clean, fully extended, and free of residue;
  • Following the rest of the instructions enclosed in the notice, including:
  • Reviewing the information with other staff trained in the use of the defibrillator;
  • Filling out and return the ‘Confirmation Response’ included with the notice; and
  • Contacting Phillips Healthcare for further information or support at 1-800-722-9377.

Affected model numbers include M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8 and M3536M9. The recall impacts devices manufactured between Feb. 11, 2004 and Nov. 4, 2016; and devices distributed between Feb. 12, 2004 and Nov. 4, 2016.

Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Reporting Program either online, by regular mail or by fax to 1-800-FDA-0178.

For more information: www.fda.gov/medicaldevices/safety

Related Content

Ophthalmic optical coherence tomography (OCT) scan view of the macula in retina with vessels. Detecting heart disease with OCT imaging of the eye.Getty Images

Ophthalmic optical coherence tomography (OCT) scan view of the macula in retina with vessels. Getty Images
 

News | Cardiac Diagnostics | March 08, 2021
March 8, 2021 — In a new study from Shiley Eye Institute at UC San Diego Health, researchers have identified a potent
Alivecor's pocket ECG system allows consumers or cardiologists to record a single lead ECG. AI algorithms can determine if their ECG is normal or abnormal and identify the arrhythmia.

Alivecor's pocket ECG system allows consumers or cardiologists to record a single lead ECG strip on a smartphone. AI algorithms can determine if their ECG is normal or abnormal and identify the arrhythmia. 

News | Cardiac Diagnostics | March 03, 2021
March 3, 2021 — AliveCor recently announced a new collaboration with AstraZeneca to research new disease management s
A study of more than 100 million Americans in 3,123 counties found a correlation between cardiac death and their level of income. Getty Images Health disparities in cardiovascular disease.

A study of more than 100 million Americans in 3,123 counties found a correlation between cardiac death and their level of income. Getty Images

News | Cardiac Diagnostics | February 02, 2021
February 2, 2021 — A new study has found in the U.S.
A new study highlights the importance of continued public education regarding the risks of cigarette smoking and the failure of dual use with vaping to reduce cardiovascular risk. Getty Images

A new study highlights the importance of continued public education regarding the risks of cigarette smoking and the failure of dual use with vaping to reduce cardiovascular risk. Getty Images

News | Cardiac Diagnostics | January 06, 2021
January 6, 2021 — Smoking traditional cigarettes in addition to using e-cigarettes results in harmful health effects
The Mesuron Inc. Avalon-H90 uses magnetometers to detect myocarditis in patients without any physical contact. It uses ventricular repolarization dynamics analysis software to look for abnormalities. The vendor said it is more specific than using ECG. It detects the multidimensional dynamics of the electrical activity caused by differences in functions of electrical action potential of normal heart tissues and abnormal ones with hypoxia.

The Mesuron Inc. Avalon-H90 uses magnetometers to detect myocarditis in patients without any physical contact. It uses ventricular repolarization dynamics analysis software to look for abnormalities. The vendor said it is more specific than using ECG. It detects the multidimensional dynamics of the electrical activity caused by differences in functions of electrical action potential of normal heart tissues and abnormal ones with hypoxia. 

News | Cardiac Diagnostics | October 06, 2020
October 6, 2020 — A new technology being developed by U.S.-based Mesuron Inc.
With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a costly tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. Amyloidosis Patient Registry  #Amyloidosis

With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. This is Figure 2, showing how SPECT imaging allows the reader to distinguish between blood pool activity (ventricular cavity, etc) and myocardial activity and identify regional myocardial differences in radiotracer uptake.

News | Cardiac Diagnostics | March 05, 2020
March 5, 2020 — More than 300 patients have joined the Amyloidosis Patient Registry and it is now available to the en
heart disease image
News | Cardiac Diagnostics | December 18, 2019
December 18, 2019 — In their latest report, “...
FDA Warns Troponin Tests Impacted by Biotin Dietary Supplement
Feature | Cardiac Diagnostics | November 05, 2019 | Dave Fornell, Editor
November 5, 2019 — The U.S.