FDA issues recalls for interventional systems from 2 big-name vendors
Two fluoroscopy systems made their way onto the U.S. Food and Drug Administration’s running list of recalled medical devices.
The systems in question are manufactured by two big names in the medical technology field—Siemens Medical Solutions and Canon Medical Systems. Both recalls are categorized as Class 2, which the FDA designates for issues that have the potential to “cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Canon’s recall of its interventional fluoroscopy system is related to the unit’s design; there is an issue with the fixing screws used in the ceiling movement gear.
“It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose,” the FDA’s notice reads. “As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed.”
Canon issued an Urgent Medical Device Correction to affected customers in late December. The letters instructed customers to stop using the device if it begins to make any abnormal noises or displays new sensor error codes. If this occurs, users should contact their Canon Service Team to inform them of the issue. Canon is working on implementing corrections. Should any users have questions or concerns in the meantime, the company recommends contacting its InTouch team at [email protected].
That recall affects a little over 300 systems distributed globally. More detailed information can be found here.
The recall of Siemens’ interventional fluoro system is related to an issue specific to image orientation. It is due to an error with the software.
“Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed,” the FDA notice reads.
Siemens also issued Urgent Medical Device Correction letters in late December, providing customers with specific instructions on how to work around the issue until a software update has been implemented. Instructions can be found here.
The software glitch affects around 40 units that are in operation globally.
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.