Philips Ingenuity Core CT Systems Recalled for Image Artifacts
Philips is recalling 18 Ingenuity Core CT systems because software version 3.5.4 may cause swirl-like artifacts on images, 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 hazard involves image quality issues requiring rescans rather than direct physical injury or death, fitting the moderate severity criteria for low-risk operational defects.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 18 Ingenuity Core Computed Tomography (CT) X-ray systems. The recall involves specific units running software version 3.5.4 that have exhibited intermittent swirl-like ring artifacts on reconstructed images.
The affected systems were distributed in California, Florida, Idaho, Kansas, Michigan, New York, Ohio, and Texas. The issue may render images unusable for interpretation, which could necessitate a patient rescan.
Healthcare facilities should contact Philips for further instructions regarding the affected serial numbers and software updates.
The recalled product
- Product
- Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 18
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 (20)
- Ingenuity Core
- System Code #728321
- Serial numbers: 310101
- 310102
- 310103
- 310104
- 310105
- 310106
- 310108
- 310109
- 310112
- 310115
- 310137
- 333006
- 333008
- 333011
- 333012
- 333013
- 333016
- 333017
Distribution
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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