|The Discovery MR750 is one of several GE MRI systems being recalled.--Courtesy of GE|
Readers had a voracious appetite for learning more about the first Class 1 recall of a nuclear magnetic resonance imaging system since at least 2007. And it affected all 12,968 GE ($GE) MRI machines manufactured since 1985.
As the result of a disabled magnetic rundown unit, which acts as an emergency off switch for MRI magnets, there were "two reported injuries when hospital employees entered the MRI room carrying a metal container," the FDA said in its recall notice.
"At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries," the recall notice warned.
As alarming as that sounds, the corrective action requested in GE's January recall letter to customers was simple a test to ensure that the magnetic rundown unit is connected to the MRI's superconducting magnet. The FDA's recall notice describes the four steps.
GE told FierceMedicalDevices after the story was published that the test takes 5 minutes to perform, and said it had already recommended that the test be done on a weekly basis.
|Magnetic rundown unit with arrows pointing to its subcomponents--Courtesy of FDA|
But in January it felt the need to send customers a reminder following a safety incident in India. Unfortunately, for GE, the FDA classified the letter's corrective action as a Class 1 recall, earning the company unfavorable publicity from FierceMedicalDevices and others who picked up on our story.
This recall is a reminder that not all recalls involve returning the affected devices, nor do they necessary imply faulty equipment. Sometimes simple reminders are needed to prevent serious safety incidents from occurring due to human error.
It's worth noting that the FDA also posted another rare Class I MRI recall on its website that day in February. Ohio's Alltech Medical Systems recalled 2 Echostar Spica MRI systems in Maryland for a similar reason, saying "the MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly."
GE recalls 10,000+ MRI systems after FDA deems them potentially deadly, citing poor training
GE explains the recall of its MRI systems to FierceMedicalDevices