IMPORTANT: Phillips recalls 47,000 units of its HeartStart MRx monitor/defibrillator (Phillips retira 47,000 unidades del Monitor/Desfibrilador HeartStart MRx) March 2017

IMPORTANT: Phillips recalls 47,000 units of its HeartStart MRx monitor/defibrillator (Phillips retira 47,000 unidades del Monitor/Desfibrilador HeartStart MRx) March 2017

Mar 24, 2017 | Tim Casey

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.”

The recall affects the following model numbers: 

M3535A (M3535ATZ) 

M3536A (M3536ATZ)

M3536M

M3536MC

M3536M2

M3536M4

M3536M5

M3536M6

M3536M7

M3536M8 

M3536M9.