The Recall Desk
HighFDA (Devices)·Z-2257-2015·Announced 2015-08-05

Philips CT Systems Recalled for Software and Hardware Defects

Philips is recalling 82 Ingenuity Core CT systems due to software errors affecting image quality, dose control, and heart rate monitoring.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which involves a risk of temporary or medically reversible adverse health consequences, and the defects affect critical diagnostic functions like dose control and heart rate monitoring.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 82 units of the Computed Tomography X-ray Systems Ingenuity Core. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data.

The recall addresses five specific issues: Fast Get Ready is incorrectly enabled during service procedures; contrast annotation is missing for some images when manual contrast was administered; a dot artifact is intermittently present after startup; heart rate measured values incorrectly remain constant for some heart rate change conditions; and DoseRight is incorrectly enabled when the Exam Card specified disabling it. Additionally, tube heat prediction issues were noted.

The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. Consumers and healthcare facilities should contact Philips Medical Systems for further instructions on how to address these defects.

The recalled product

Product
Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
82

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 #728321
  • Serial #s: 31001
  • 52007
  • 52008
  • 52010
  • 52012
  • 52013
  • 52018
  • 52020
  • 52021
  • 52024
  • 52026
  • 52030
  • 52031
  • 52032
  • 52033
  • 52034
  • 52035
  • 52036
  • 52037

Distribution

Distributed nationwide across the United States.

The notice also names 33 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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