Philips Brilliance 16 Air CT Systems Recalled for Collimator Defect
Philips is recalling 23 Brilliance 16 Air CT systems because a collimator component may fail, causing image artifacts.
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. The hazard involves image quality degradation (artifacts) rather than direct physical injury or death, fitting the criteria for a moderate severity issue involving a functional defect without reported harm.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 23 Brilliance 16 Air Computed Tomography (CT) 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 on the images produced by the device.
The firm identified that these systems are at risk because the collimator compensator has exceeded its expected lifetime usage. The affected units were distributed only to China and the United Kingdom.
No specific instructions for consumers are provided in the source text, as the distribution was limited to specific international markets. The recall number is Z-1142-2019.
The recalled product
- Product
- Brilliance 16 Air, 728246 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
- Affected units
- 23
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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