Philips CT Systems Recalled for Unintended Radiation Performance Issues
Philips is recalling Brilliance CT 64 systems due to an unintended radiation issue that could affect equipment performance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a performance issue affecting radiation, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips North America LLC is recalling Philips Brilliance CT 64 systems, including specific channel and upgrade product codes, due to an identified unintended radiation issue. The recall also covers Philips IQon, iCT, and Ingenuity CT systems.
The issue could affect the performance of the equipment. The affected products were distributed in the US and US Territories.
Consumers and healthcare facilities should contact Philips for further instructions regarding the recall and necessary corrective actions.
The recalled product
- Product
- Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — CT Scanner
Distribution
Distribution scope not specified by the agency.
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