The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0009-2017·Announced 2016-10-12

Philips Brilliance 64 CT Scanner Recalled for Infant Head Image Quality Issues

Philips Medical Systems is recalling 185 Brilliance 64 CT scanners because infant head scans in High Resolution mode may show degraded image quality.

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 source text does not report any hospitalizations, injuries, or deaths. The hazard is limited to degraded image quality, which aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary measures without reported harm.

Plain-English summary

Philips Medical Systems is recalling 185 units of the Brilliance 64 CT Model Number 728231. 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, a 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 and do not experience this issue.

The recalled product

Product
Brilliance 64 CT Model Number 728231 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 — Imaging Equipment
Hazard
Affected units
185

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)

  • 4001
  • 4016
  • 5169
  • 9056
  • 9071
  • 9074
  • 9099
  • 9112
  • 9134
  • 9251
  • 9280
  • 9367
  • 9515
  • 9529
  • 9538
  • 9541
  • 9548
  • 9549
  • 9554
  • 9559

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 →

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