The Recall Desk
ModerateFDA (Devices)·Z-0176-2016·Announced 2015-11-04

Philips Ingenuity Core 128 CT Systems Recalled for X-ray Measurement Error

Philips Medical Systems is recalling 109 Ingenuity Core 128 CT systems due to X-ray measurement errors causing image artifacts.

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 source text does not report any hospitalizations, injuries, or deaths. The hazard is a technical defect (image artifacts) without reported harm, fitting the criteria for a moderate severity score.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 109 units of the Ingenuity Core 128 Computed Tomography X-ray systems. These devices are intended to produce cross-sectional images of the body. The recall covers units distributed worldwide, including the United States and numerous international countries.

The firm discovered that the affected systems exhibit Ring/Dot artifacts due to X-ray measurement error. This defect affects the image quality produced by the equipment. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

Healthcare facilities and consumers with these specific serial numbers should contact Philips Medical Systems for further instructions on the recall. The affected model number is 728323, and the specific serial numbers are listed in the official recall documentation.

The recalled product

Product
Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography
Hazard
Affected units
109

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)

  • Model No. 728323
  • S/N: 30153
  • 32001
  • 32002
  • 32003
  • 32004
  • 32005
  • 32006
  • 32007
  • 32009
  • 32011
  • 32012
  • 32014
  • 32017
  • 32019
  • 32020
  • 32022
  • 32023
  • 32024
  • 32025

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 6 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 6 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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