'Unintended radiation issue' prompts recall of several CT systems

Several computed tomography systems manufactured by Philips are the subject of a new recall by the U.S. Food and Drug Administration. 

The Philips IQon, iCT, Ingenuity, and Brilliance CT 64 were each added to the FDA’s list of medical device recalls on Sept. 1. The recall was issued due to “an unintended radiation issue,” which the company says could potentially affect the performance of its products.

The information included in the recall record did not further elaborate on the radiation issue nor indicate whether it was due to higher or lower than expected exposure. However, since it falls under the category of a Class 2 recall, which indicates the chances of serious harm are remote, it is unlikely that the issue would impact patients’ physical well-being. 

Philips says that affected customers will be notified via Electronic Product Radiation Correction notification dated August 2026. The good news is that the solution is a simple software fix, which will be implemented by Philips free of charge. The company is reaching out to affected customers to schedule the fix but encourages anyone with questions or concerns to reach Philips at 800-722-9377 and use the reference number 2025-PD-CTAMI-014. 

These systems are in use globally and are in operation throughout the United States. The recall does not specify the number of impacted units, but the systems are among some of the most widely installed in the U.S. 

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