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