The Recall Desk
ModerateFDA (Devices)·Z-2116-2016·Announced 2016-07-06

Philips Brilliance 64 CT Scanner Recall for Image Artifacts

Philips is recalling 94 Brilliance 64 CT scanners due to intermittent swirl-like ring artifacts on images, which may require patient rescans.

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, but the hazard is limited to image quality issues requiring rescans rather than direct physical injury or death, fitting the moderate severity criteria for low-risk operational defects.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 94 Brilliance 64 Computed Tomography (CT) X-ray systems. The recall affects systems running software version 3.5.4 that have exhibited intermittent swirl-like ring artifacts on reconstructed images.

The affected units were distributed nationwide in the states of California, Florida, Idaho, Kansas, Michigan, New York, Ohio, and Texas. The specific serial numbers for the affected units are listed in the official recall documentation.

If the artifacts prevent the images from being used for interpretation, a patient rescan may be required. Healthcare facilities should contact Philips Medical Systems for further instructions on resolving the issue.

The recalled product

Product
Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
94

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)

  • Brilliance 64: System Code #728231 Serial numbers: 9847
  • 9936
  • 9937
  • 9963
  • 10067
  • 10146
  • 10155
  • 10181
  • 10184
  • 10189
  • 10191
  • 10216
  • 10240
  • 10292
  • 10768
  • 10769
  • 10770
  • 10771
  • 10772
  • 10773

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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Same hazard · image artifact

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