The Recall Desk
ModerateFDA (Devices)·Z-2117-2016·Announced 2016-07-06

Philips Ingenuity Core CT Systems Recalled for Image Artifacts

Philips is recalling 18 Ingenuity Core CT systems because software version 3.5.4 may cause swirl-like artifacts on images, potentially requiring 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 involves 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 18 Ingenuity Core Computed Tomography (CT) X-ray systems. The recall involves specific units running software version 3.5.4 that have exhibited intermittent swirl-like ring artifacts on reconstructed images.

The affected systems were distributed in California, Florida, Idaho, Kansas, Michigan, New York, Ohio, and Texas. The issue may render images unusable for interpretation, which could necessitate a patient rescan.

Healthcare facilities should contact Philips for further instructions regarding the affected serial numbers and software updates.

The recalled product

Product
Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core 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 an
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography (CT) Scanner
Hazard
Affected units
18

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)

  • Ingenuity Core
  • System Code #728321
  • Serial numbers: 310101
  • 310102
  • 310103
  • 310104
  • 310105
  • 310106
  • 310108
  • 310109
  • 310112
  • 310115
  • 310137
  • 333006
  • 333008
  • 333011
  • 333012
  • 333013
  • 333016
  • 333017

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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