A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The HeartStart MRx monitor/defibrillator is designed to deliver lifesaving electrical shocks to people with sudden cardiac arrest or to pace individuals with a slow heart beat, according to the FDA.
Electrodes on the unit are attached to the patient and then connected to the device to help it analyze the patient’s heart rhythm and deliver electrical shots to restore a normal heart rhythm.
The company is recalling the units due to electrical and battery connection issues which could prevent the device from powering up, charging and delivering electrical shock therapy, and could stop corrective pacing. The FDA said that a delay in delivery such therapy could result in serious patient injury.
The recall affects approximately 47,362 units across the US with model numbers M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8 and M3536M9, manufactured between Feb. 11, 2004 and Nov. 4, 2016 and distributed between Feb. 12, 2004 and Nov. 4, 2016.
Philips began notifying customers of the issue in Feb., according to the FDA.