The Recall Desk
ModerateFDA (Devices)·Z-0695-2017·Announced 2016-12-14

Philips Ingenuity Core CT Systems Recalled for Software Error

Philips Medical Systems is recalling 337 Ingenuity Core CT systems worldwide due to a software error involving the filament on timer.

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 does not report any injuries, illnesses, or hospitalizations, and the hazard is a software error without explicit mention of high-risk pathogens or structural defects, fitting the criteria for a moderate severity score.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 337 units of the Ingenuity Core 728321 Computed Tomography X-ray systems. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data.

The recall is due to a software error associated with the filament on timer. The affected units were distributed worldwide, including in the United States and numerous international locations.

No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.

The recalled product

Product
Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography (CT) Systems
Hazard
Affected units
337

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)

  • 30041
  • 31001
  • 33084
  • 52000
  • 52004
  • 52007
  • 52008
  • 52010
  • 52012
  • 52013
  • 52014
  • 52015
  • 52018
  • 52019
  • 52020
  • 52021
  • 52022
  • 52024
  • 52025
  • 52026

Distribution

Distributed in 46 states:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

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