Phillips recalled the HeartStart MRx monitor/defibrillator after discovering electrical and battery connection issues that could prevent the device from powering up, charging and delivering an electrical shock therapy.
The FDA announced the recall in a safety alert posted on the agency’s website on March 24.
Phillips recalled 47,632 units in the U.S. that were manufactured from Feb. 11, 2004, to Nov. 4, 2016, and distributed from Feb. 12, 2004, to Nov. 4, 2016.
Medical professionals who are trained in CPR use the HeartStart MRX to pace people with a slow heartbeat or deliver shocks to people with sudden cardiac arrest.
In February, Phillips sent an “Urgent Medical Device Correction” notice to its customers, according to the FDA. The company said that the device could stop pacing and lead to delays in delivering therapy, which could result in permanent organ damage, brain injury or death.
The FDA classified the action a Class I recall, which the agency defines as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”