The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0545-2016·Announced 2015-12-30

Philips Brilliance iCT CT System Recalled for Perfusion Software Issue

Philips is recalling 51 Brilliance iCT CT systems because the perfusion scan feature may be unavailable on specific software versions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 hazard involves a software feature availability issue rather than a direct physical safety risk, and no injuries or illnesses are reported, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 51 units of the Brilliance iCT Computed Tomography X-ray system. The recall involves Model No. 728306 units with specific serial numbers distributed worldwide, including the United States, Australia, and various countries in Europe, Asia, and the Middle East.

The recall is issued because the perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers who previously used the basic axial perfusion software without purchasing the helical perfusion license key were unable to access the basic axial perfusion feature after upgrading to software version 4.1.2.

The source text does not specify the corrective action or instructions for consumers. No injuries or illnesses are reported in the source text.

The recalled product

Product
Brilliance iCT Computed Tomography X-ray system
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography
Hazard
Affected units
51

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 No. 728306
  • S/N: 85015
  • 85021
  • 85028
  • 85034
  • 85036
  • 85039
  • 85042
  • 85047
  • 85051
  • 100030
  • 100038
  • 100040
  • 100051
  • 100054
  • 100058
  • 100065
  • 100072
  • 100093
  • 100094

Distribution

Distributed nationwide across the United States.

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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