GE Healthcare warned customers about a safety issue involving MRI machines made over a period of nearly 30 years, after a single human error incident in India revealed that a key safety function can be disabled.
According to FDA, two hospital employees who entered an MRI room carrying a metal container have been injured due to these machines. The recall, affecting MRI machines manufactured and distributed between 1985 and December 2014, has been labeled as a Class I, meaning the issue can cause serious injury or death.
GE Healthcare has warned that service personnel may have modified the affected MRI machines to disable the magnet rundown unit, which helps shut down the magnetic field in emergencies. In early January , GE Healthcare’s urgent medical device correction walked customers through confirming that the magnet rundown unit is properly connected to the magnet. In a Feb. 21 follow-up, GE clarified that the “U.S. FDA notice was not related to any manufacturing defect or product related error.” Rather, the company said, the action stems from “a case of human error on site.”
GE said that the MRI machine check to ensure the magnetic rundown unit is still connected will take about 5 minutes. Once technicians confirm the magnetic rundown unit is connected and functioning (a process the company said should be done weekly), then the MRI system can be used as normal. “Maintaining a high level of safety and quality is a priority for GE Healthcare,” the company said.