Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0017-2018·Announced 2017-10-25

Philips Ingenuity CT Systems Recalled for Bolus Tracking Image Failure

Philips is recalling Ingenuity CT systems because a software defect prevents image generation during bolus tracking procedures, 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 resulting in a rescan rather than a direct physical injury or hospitalization, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Philips Electronics North America Corporation is recalling 606 units of the Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed system in the United States. The recall affects systems running software version 4.16.

The recall was initiated because a discrepancy between the calculated reconstruction length and the actual scan length prevents the system from generating images when a bolus tracking procedure is completed. Additionally, the raw data file is not available for offline reconstruction. This defect may result in the operator choosing to rescan the patient.

Healthcare facilities and users of these systems should contact Philips for further instructions regarding the recall and necessary corrective actions.

The recalled product

Product: Philips Healthcare Ingenuity CT 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
imaging-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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