FDA denies petition to reclassify MRI safety event
The U.S. Food and Drug Administration has denied a petition to reclassify certain MRI safety incidents as “malfunctions.”
Currently, projectile incidents that occur within MRI suites are classified as “use errors.” This definition excludes such events from Original Equipment Manufacturer reporting; altering the terminology to describe the events as malfunctions would change that, as there is a requirement that events related to malfunctions be reported.
In April of 2025, MRI safety expert Tobias Gilk, MR architect and founder of Gilk Radiology Consultants, petitioned the FDA to reclassify projectile incidents. Gilk argued that there should be a requirement that these events be reported to the FDA by manufacturers even if they do not result in staff or patient harm; in doing so, this would promote a safer environment for patients and staff.
In his petition, Gilk stated that “if these incidents are few and far between, then the incremental reporting cost will be negligible. However, if these incidents are (as we suspect) frequent, then they likely represent a significant undisclosed post-market risk that warrants the attention of both the FDA and industry.”
Last week, the FDA denied the petition. The agency cited its own Medical Device Reporting for Manufactures guidance that stipulates that manufacturers are required to report events related to incidents that are caused by equipment malfunctions that could result in serious harm or death if the malfunction were to recur. Although that guidance defines malfunction, it does not offer a specific definition for “user error.” The FDA stated that the benefits of reporting near misses owed to user error “would likely be minimal.”
Gilk shared his feelings on the FDA’s decision in a LinkedIn post.
“I'm sorry (but not terribly surprised) to report that the FDA has denied the petition,” Gilk wrote. “Despite the fact that malfunction is very widely defined, and there is no real statutory definition of user error, the FDA has ruled that projectile incidents are *not* malfunctions.”
In its response, the FDA noted that although near miss events related to user error are not required to be reported, manufacturers are welcome to disclose them voluntarily, when made aware.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.