The FDA gave the recall a Class II label, reserved for "products that might cause a temporary health problem, or pose only a slight threat of a serious nature."
The FDA noted and Philips confirmed that there are about 65,000 MRx devices affected by the recall worldwide. The company has developed a software update and plans to contact each customer in the near future in order to schedule a repair, Philips spokesman Mario Fante told MassDevice.com via email.
The software glitch in the MRx systems, which are used by emergency medical response teams, may prevent the device from delivering life-saving therapy when operating in certain modes, specifically the "Manual Defib" or "AED" modes. The devices’ "Pacer" mode is unaffected, according to to a company alert.
"At this time there have been 2 reports of patient harm," according to a company statement. "Philips is notifying all affected customers and will provide a software correction free of charge."
Philips issued a alert in April and an updated notice in May. U.K. healthcare regulators asked local clinics make sure that they have access to an alternative defibrillator until the MRx systems have been updated.