The Recall Desk
ModerateFDA (Devices)·Z-0011-2017·Announced 2016-10-12

Philips Ingenuity Core 128 CT Scanner Recalled for Image Quality Defects

Philips Medical Systems is recalling 524 Ingenuity Core 128 CT scanners because high-resolution head scans may produce degraded image quality, including non-uniformity and CT number shifts.

What this means for you

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 hazard involves degraded image quality (non-uniformity, CT number shift) which could impact diagnostic accuracy, but the source text does not report any hospitalizations, serious injuries, or deaths, fitting the criteria for a moderate severity recall involving potential harm without reported adverse events.

Plain-English summary

Philips Medical Systems is recalling 524 units of the Ingenuity Core 128 Computed Tomography (CT) X-ray system, Model Number 728323. These systems are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data. The recall covers units distributed worldwide, including nationwide distribution across the United States and in numerous international countries.

The recall is due to a failure in the infant performance test for the Infant Head Uniformity test with High Resolution. As a result, when users perform High Resolution head scans, the reconstructed images may exhibit degraded image quality. This degradation is manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and a reduction in gray/white matter differentiation. The issue is most severe in High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution by default. Adult head scans, which default to standard resolution, do not experience this issue.

Healthcare facilities and users of these devices should contact Philips Medical Systems for further instructions on how to address the defect. The source text does not specify a specific action for consumers, as these are medical devices used by professionals.

The recalled product

Product
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Manufacturer
Philips Medical Systems
Category
Medical Device — Computed Tomography (CT) Scanner
Hazard
Affected units
524

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)

  • 30016
  • 30023
  • 30024
  • 30151
  • 32000
  • 32001
  • 32008
  • 32010
  • 32012
  • 32013
  • 32015
  • 32016
  • 32018
  • 32021
  • 32022
  • 32024
  • 32026
  • 32028
  • 32032
  • 32033

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Philips Medical Systems 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 4 products in this recall →

Related recalls

Same manufacturer · Philips Medical Systems

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Same hazard · image quality defect

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