Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2118-2016·Announced 2016-07-06

Philips Ingenuity Core 128 CT Scanner Recalled for Image Artifacts

Philips is recalling 19 Ingenuity Core 128 CT scanners 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 is limited to image quality issues requiring rescans with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 19 Ingenuity Core 128 Computed Tomography X-ray systems. The recall involves systems running software version 3.5.4 that have exhibited intermittent swirl-like ring artifacts on reconstructed images. The affected units were distributed nationwide in California, Florida, Idaho, Kansas, Michigan, New York, Ohio, and Texas.

The hazard is that the swirl-like artifacts may render images unusable for interpretation, which may require a patient rescan. The source text does not report any injuries or illnesses associated with this defect.

Healthcare facilities should identify affected units by checking the system code and serial numbers listed in the recall notice. If images are affected, a rescan may be necessary to ensure accurate diagnostic interpretation.

The recalled product

Product: Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 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…
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Computed Tomography (CT) Scanner
Hazard: image-artifact
diagnostic-error
Affected units: 19

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 Core128:System Code #728323
Serial numbers: 320001
320016
320076
320077
320080
320085
320086
320087
320088
320089
320091
320113
336001
336002
336003
336006
336007
336008
336009

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

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.

See all 3 products in this recall →

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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