Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0175-2016·Announced 2015-11-04

Philips Ingenuity Core CT Systems Recalled for X-ray Measurement Error

Philips is recalling 36 Ingenuity Core CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

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. The source text describes a measurement error causing image artifacts but does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall involving a defect without reported harm.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 36 units of the Ingenuity Core Computed Tomography X-ray systems. These systems are intended to produce cross-sectional images of the body. The recall covers Model No. 728321 with specific serial numbers listed in the agency record.

The firm discovered that the affected systems produce Ring/Dot artifacts due to an X-ray measurement error. This defect affects the accuracy of the images produced by the equipment.

The affected units were distributed worldwide, including nationwide in the United States and in numerous countries across Europe, Asia, Africa, and the Americas. No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the defect.

The recalled product

Product: Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Imaging Equipment
Hazard: measurement-error
image-artifact
Affected units: 36

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)

Model No. 728321
S/N: 52000
52001
52002
52003
52004
52006
52009
52011
52012
52015
52016
52017
52020
52022
52025
52027
52029
310116
310150

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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