Philips Brilliance 64 CT Systems Recalled for Image Artifacts
Philips is recalling 14 Brilliance 64 CT systems because a component may fail, causing ring or smudge artifacts on images.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to image quality artifacts (ring or smudge) without reported injuries, hospitalizations, or structural defects that pose a direct physical safety risk to patients.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 14 Brilliance 64 Computed Tomography (CT) X-ray systems. The recall is due to a potential failure of the compensator within the X-ray tube collimator. This failure can result in ring or smudge artifacts appearing on the images produced by the device.
The affected systems are identified as being at risk because the collimator compensator has exceeded its expected lifetime usage. The recall number is Z-1143-2019. The agency classification for this recall is Class II.
The source text states that these systems were distributed only to China and the UK. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.
The recalled product
- Product
- Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 14
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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