The Recall Desk
HighFDA (Devices)·Z-2259-2015·Announced 2015-08-05

Philips Ingenuity CT Scanners Recalled for Software and Hardware Defects

Philips is recalling 159 Ingenuity CT scanners due to software errors affecting dose control, image artifacts, and heart rate measurement.

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, and the defects involve incorrect dose control and image artifacts which pose a risk of harm, but no injuries or illnesses have been reported.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 159 units of the Ingenuity CT scanner, a medical device intended to produce cross-sectional images of the body. The recall is due to five identified 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.

The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. The specific model number is 728326, and the recall covers a specific list of serial numbers provided in the agency documentation.

Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve these defects. The source text does not report any specific injuries or illnesses associated with these defects.

The recalled product

Product
Computed Tomography X-ray Systems Ingenuity CT scanners. 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 — Computed Tomography (CT) Scanner
Hazard
Affected units
159

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 #728326
  • Serial #s: 30003
  • 30004
  • 30005
  • 30006
  • 30007
  • 30008
  • 30009
  • 30011
  • 30012
  • 30013
  • 30015
  • 30018
  • 30019
  • 30020
  • 30025
  • 32086
  • 32093
  • 32107
  • 52023

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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