FDA announces recall of imaging systems that have the 'potential to produce fire'
Philips North America has issued a series of urgent recalls related to its nuclear medicine MR imaging systems.
The Class 2 recalls were implemented due to concerns the imaging equipment could cause serious adverse health consequences. They pertain to a problem within the systems’ design.
“The potential for component failures in the gradient coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire,” each of the July 30 recalls read.
The following are all listed on the FDA’s Medical Device Recalls list for the same issue:
Combined, the recalls cover thousands of Philips nuc med MR scanners. Philips reached out to affected customers on June 30 with instructions (found here) on how to prevent risks for patients and staff. If the troubleshooting guidance does not resolve the issue, users are instructed to not attempt any scans on patients or phantoms until system has been checked and released by a Philips Service representative.
The Customer Care Solutions team can be reached via phone at 800-722-9377.
Visit the FDA’s website for more detailed information specific to which model numbers are affected by the recall.
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.