Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Failure
Philips is recalling Ingenuity Core128 CT systems because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patient rescans.
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 source text describes a functional defect leading to potential rescans without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity issue.
Plain-English summary
Philips Electronics North America Corporation is recalling 606 units of the Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed systems. 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 involves systems running software version 4.16 that were distributed nationwide in the United States.
The recall is due to a software defect that occurs during bolus tracking procedures. 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 choose to rescan the patient. No specific injuries or illnesses are reported in the source text. Healthcare facilities should contact Philips for instructions on how to address the software issue and manage affected patient data.
The recalled product
- Product
- Philips Healthcare Ingenuity Core128 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
- Hazard
- 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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