The Recall Desk
ModerateFDA (Devices)·Z-0010-2017·Announced 2016-10-12

Philips CT Scanner Recall for Infant Head Image Quality Defects

Philips is recalling 358 Ingenuity Core CT scanners because infant head scans may show 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 scans, which is a significant diagnostic risk, but the source text does not report any hospitalizations, serious injuries, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

Philips Medical Systems is recalling 358 Ingenuity Core Model Number 728321 Computed Tomography (CT) X-ray systems. These systems are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data.

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, and the factory reference pediatric scan protocols are set to High Resolution by default. Adult head scans use a standard resolution protocol that does not experience this issue.

The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. Consumers and healthcare providers should contact Philips Medical Systems for further instructions regarding the recall and potential corrective actions.

The recalled product

Product
Ingenuity Core Model Number 728321 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
358

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)

  • 30041
  • 31001
  • 33084
  • 52000
  • 52004
  • 52007
  • 52008
  • 52010
  • 52012
  • 52013
  • 52014
  • 52015
  • 52018
  • 52019
  • 52020
  • 52021
  • 52022
  • 52024
  • 52025
  • 52026

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

See all →

Same hazard · image quality defect

See all →