Philips Brilliance iCT SP CT Systems Recalled for Image Reconstruction Failure
Philips is recalling Brilliance iCT SP CT systems because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patients to be rescanned.
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 source text describes a functional defect leading to the need for rescans without reporting any injuries, hospitalizations, or deaths. This aligns with a moderate severity rating for a risk-of-harm product where injury has not yet been reported but the defect is significant enough to warrant a Class II classification.
Plain-English summary
Philips Electronics North America Corporation is recalling 606 units of the Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed systems in the United States. The recall involves units running Software 4.16.
The recall is due to a software defect that can occur during a bolus tracking procedure. In affected cases, no images are generated when the scan is completed, and the raw data file is not available for offline reconstruction. This issue is caused by a discrepancy between the calculated reconstruction length and the actual scan length, which results in the inability to reconstruct the raw data.
The primary consequence of this defect is that the operator may need to rescan the patient to obtain the necessary images. No specific injuries or illnesses have been reported in the source text.
The recalled product
- Product
- Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 606
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)
- Software 4.16
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Philips Electronics North America Corporation 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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