Cardiac Science’s voluntary field correction for a suite of automated external defibrillators got Class I recall status from the FDA over concerns that a failed component may keep the device from providing life-saving therapy during a heart attack.
The company’s PowerHeart G3 AEDs are mobile devices, often found in hospitals, schools or physicians’ offices, intended to be used by trained personnel to deliver defibrillation therapy to someone suffering sudden cardiac arrest.
Due to a defective circuit board component, which the company explained was the result of a supplier manufacturer issue, the devices may suddenly fail to provide defibrillation.
The issue was detected at the Cardiac Science factory through the company’s quality-control processes, according to a press release. As yet, there have been no reported instances of the devices failing to deliver shock therapy.
There are currently about 11,000 units active around the world, according to an FDA release.
Cardiac sent an "urgent voluntary medical device recall" to its customers Jan. 13, asking them to immediately return the affected devices for repair.
In other recall news, Flight Medical Ltd. landed Class I status for a cable used as an accessory for its Newport HT50 ventilators. The cables were recalled because they may cause an electrical short that could cause the ventilator to shut down unexpectedly, according to an FDA alert.
There are a total of 328 affected cables distributed in the U.S., according to the report.