GE explains the recall of its MRI systems to FierceMedicalDevices

FierceMedicalDevices broke the news Friday of GE's ($GE) recall of virtually all of its MRI machines manufactured since 1985. Soon thereafter GE told FierceMedicalDevices in an email that the recall was voluntarily initiated following a single safety incident in India, where some users had disabled the so-called magnetic rundown unit, because the company "wanted to ensure that the human error was not occurring at other sites globally." The company sent a letter to customers in January urging them to ensure that the magnetic rundown unit is connected to the MRI's superconducting magnet by performing a four-part test. GE said the magnetic rundown rundown unit is an emergency off switch for the magnet. "It is a common industry practice to have an 'emergency off switch' for the magnet, which should be checked regularly. GE Healthcare already recommends that this check be done weekly. Once the 5-minute check is confirmed, MRI operations can continue as normal," the email says. GE originally disclosed its action in a Feb. 4 press release, before the FDA classified the event as a Class I recall, meaning there there is a "reasonable probability" that the device "will cause serious adverse health consequences or death." Almost 13,000 GE MRIs are affected. GE's statement

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