The Recall Desk
ModerateFDA (Devices)·Z-0175-2016·Announced 2015-11-04

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

Philips is recalling 36 Ingenuity Core CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

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 source text describes a measurement error causing image artifacts but does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall involving a defect without reported harm.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 36 units of the Ingenuity Core Computed Tomography X-ray systems. These systems are intended to produce cross-sectional images of the body. The recall covers Model No. 728321 with specific serial numbers listed in the agency record.

The firm discovered that the affected systems produce Ring/Dot artifacts due to an X-ray measurement error. This defect affects the accuracy of the images produced by the equipment.

The affected units were distributed worldwide, including nationwide in the United States and in numerous countries across Europe, Asia, Africa, and the Americas. No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the defect.

The recalled product

Product
Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
36

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. 728321
  • S/N: 52000
  • 52001
  • 52002
  • 52003
  • 52004
  • 52006
  • 52009
  • 52011
  • 52012
  • 52015
  • 52016
  • 52017
  • 52020
  • 52022
  • 52025
  • 52027
  • 52029
  • 310116
  • 310150

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 →

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