Phillips HeartStart Rx Defibrillator Recall Issued Over Electrical Problems

Federal regulators have issued a Class I recall for nearly 50,000 emergency defibrillators distributed nationwide, warning that certain Phillips HeartStart MRx devices may not work correctly when needed to save a patient’s life. 

A Phillips HeartStart MRx Monitor/Defibrillator recall was announced by the FDA on March 24, indicating that the device may pose a risk of severe injury or death.

The FDA warns that certain defibrillators may experience electrical or battery connection problems, preventing it from powering up when needed. The problem may also prevent the device from charging properly or delivering the lifesaving electrical shock when needed most. It may also unexpectedly stop pacing a person’s heart during use.

The recall notice indicates the Phillips HeartStart defibrillator may delay delivery of needed electrical therapy to a person in a life threatening situation, such as someone who is experiencing cardiac arrest. This could result in serious patient injury, permanent organ damage, brain injury, or death.

An emergency defibrillator is used to pace a person’s heart when it has an abnormally slow heart beat or deliver a lifesaving electrical shock to someone who experienced sudden cardiac arrest. The device is intended to be used by medical professionals trained in CPR.

Devices affected by the recall include Phillips HeartStart MRx monitor/defibrillators with model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.

The devices affected by the recall were manufactured February 11, 2004, to November 4, 2016. The Phillips HeartStart monitor/defibrillator was distributed February 12, 2004, to November 4, 2016.

Phillips sent an “Urgent Medical Device Correction” notice to customers warning them about the serious issue. The notice also included instructions concerning the recall, indicating the problem and how to verify if the device in question is affected by the recall.

The notice asked customers to identify the affected devices using the model number and inspect the battery connector pins to ensure they are clean, fully extended and free of residue. The company also included instructions on how to return the device, complete the confirmation response and return the product to Phillips.

The FDA is calling for any adverse events related to the recalled defibrillators to be reported to the FDA MedWatch Adverse Event Reporting Program.