Philips Brilliance CT Systems Recalled for Unintended Radiation Issue
Philips is recalling Brilliance CT systems due to an unintended radiation issue that could affect equipment performance.
What this means for you
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 radiation issue that could affect performance, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Philips North America LLC is recalling specific models of the Philips Brilliance CT systems, including the Brilliance iCT, Brilliance iCT Upgrades, and Brilliance iCT SP, running software version 4.1.10.x. The recall is due to an identified unintended radiation issue that could affect the performance of the equipment.
The affected products were distributed in the US and US Territories. The recall covers product codes 728306, 728305, and 728311. The UDI for the Brilliance iCT is (01)00884838059474, while UDIs for the Upgrades and SP models are not available.
Healthcare facilities should contact Philips North America LLC for further instructions on how to address the radiation issue and ensure the equipment is functioning correctly.
The recalled product
- Product
- Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — CT Scanner
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI for Brilliance iCT: (01)00884838059474
- UDI for Brilliance iCT Upgrades: N/A
- UDI for Brilliance iCT SP: N/A.
Distribution
Distribution scope not specified by the agency.
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