Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0016-2018·Announced 2017-10-25

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.

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 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
Category: Medical Device — Computed Tomography
Hazard: software-defect
image-reconstruction-failure
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.

See all 6 products in this recall →

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · software defect