The Recall Desk
HighFDA (Devices)·Z-2255-2015·Announced 2015-08-05

Philips Brilliance iCT CT Systems Recalled for Software and Hardware Defects

Philips is recalling 38 Brilliance iCT CT systems due to software errors affecting dose control, heart rate measurement, and image artifacts.

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 involves a medical device with defects that could lead to incorrect radiation dosing (DoseRight) and inaccurate patient monitoring (heart rate), representing a risk of harm where injury has not yet been reported.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 38 units of the Brilliance iCT Computed Tomography (CT) X-ray system. The recall is due to five identified issues: Fast Get Ready incorrectly enabled during service procedures, missing contrast annotation for some images when manual contrast was administered, intermittent dot artifacts after startup, heart rate measured values incorrectly remaining constant for some heart rate change conditions, and DoseRight 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 serial numbers for the affected Brilliance iCT units (Model #728306) are listed in the official recall documentation.

Healthcare facilities should contact Philips Medical Systems (Cleveland) Inc to arrange for the necessary service or corrective actions to address these software and hardware defects.

The recalled product

Product
Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. 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
38

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)

  • Brilliance iCT: Model #728306
  • Serial #s: 85012
  • 85013
  • 85014
  • 100029
  • 100038
  • 100040
  • 100053
  • 100058
  • 100094
  • 100099
  • 100133
  • 100140
  • 100162
  • 100178
  • 100236
  • 100244
  • 100373
  • 100399
  • 100408

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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