The Recall Desk
ModerateFDA (Devices)·Z-0012-2017·Announced 2016-10-12

Philips Ingenuity CT Scanner Recalled for Infant Head Image Quality Issues

Philips Medical Systems is recalling 235 Ingenuity CT scanners because infant head scans in High Resolution mode 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 in infant head scans, which is a significant diagnostic concern but does not involve reported injuries, deaths, or structural defects that would warrant a higher severity score under the rubric.

Plain-English summary

Philips Medical Systems is recalling 235 units of the Ingenuity CT Model Number 728326. These computed tomography X-ray 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. 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, which is the default setting for factory reference pediatric scan protocols. Adult head scans use a standard resolution default that does 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 consumer action for individual patients, but the recall is directed at the medical device users who operate the scanners.

The recalled product

Product
Ingenuity CT Model Number 728326 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
235

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)

  • 30003
  • 30004
  • 30005
  • 30006
  • 30007
  • 30008
  • 30009
  • 30010
  • 30011
  • 30012
  • 30013
  • 30014
  • 30015
  • 30017
  • 30018
  • 30019
  • 30020
  • 30021
  • 30022
  • 30025

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 degradation

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