The Recall Desk
HighFDA (Devices)·Z-0831-2014·Announced 2014-02-05

Philips Brilliance iCT Systems Recalled for Potential Image Artifacts

Philips Medical Systems is recalling Brilliance iCT and iCT SP systems because an artifact resembling a thrombus may appear on images.

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. The hazard involves a potential diagnostic error (artifact resembling thrombus) which poses a risk of harm, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 506 units of the Brilliance iCT and Brilliance iCT SP systems. These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. The recall is due to a potential defect where an artifact that resembles a thrombus may appear on the image.

The affected units were distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international countries. The recall covers specific model numbers 728306 and 728311 with a wide range of serial numbers listed in the official notice.

Healthcare facilities and consumers should contact Philips Medical Systems for further instructions on how to address this issue. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

Product
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment su
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
506

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 # 728306 100016
  • 100018
  • 100019
  • 100020
  • 100021
  • 100022
  • 100023
  • 100024
  • 100025
  • 100028
  • 100031
  • 100032
  • 100037
  • 100038
  • 100039
  • 100040
  • 100042
  • 100043
  • 100044
  • 100045

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

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