Philips Ingenuity Core CT Systems Recalled for Image Reconstruction Failure
Philips is recalling 606 Ingenuity Core CT systems in the US because a software defect prevents image reconstruction after bolus tracking scans.
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 does not report any injuries, illnesses, or hospitalizations. The hazard is a functional failure requiring a rescan, which aligns with the 'Moderate' criteria for low-risk issues without reported harm.
Plain-English summary
Philips Electronics North America Corporation is recalling 606 units of the Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed systems in the United States. The recall involves software version 4.16. 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.
The recall is due to a software defect that occurs during bolus tracking procedures. In affected cases, no images were generated when the scan was completed, and the raw data file was 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 raw data.
The operator may choose to rescan the patient if this issue occurs. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Philips Healthcare Ingenuity Core 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 version 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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