Philips Brilliance iCT CT Scanners Recalled for Collimator Compensator Failure
Philips is recalling two Brilliance iCT CT scanners because a component may fail, causing image artifacts. The devices were distributed only to China and the UK.
What this means for you
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 artifacts (ring or smudge) without reported injuries or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling two units of the Brilliance iCT, model 728306, computed tomography (CT) scanners. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data.
The recall is due to a potential failure of the compensator within the X-ray tube collimator. This failure may result in ring or smudge artifacts on the images produced by the scanners. The firm identified these specific systems as being at risk because the collimator compensator has exceeded its expected lifetime usage.
The affected units were distributed only to China and the UK. No specific instructions for consumers are provided in the source text, as these are medical devices typically managed by healthcare facilities.
The recalled product
- Product
- Brilliance iCT, 728306 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 equip
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 2
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 (1)
- 85028 100094
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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