The Recall Desk
Agency classClass IIOur severity:LowFDA (Devices)·Z-0544-2016·Announced 2015-12-30

Philips Brilliance 64 CT System Recalled for Perfusion Software Issue

Philips is recalling 30 Brilliance 64 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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall addresses a software feature availability issue rather than a physical safety hazard or risk of injury, fitting the criteria for low severity.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 30 units of the Brilliance 64 Computed Tomography X-ray system. The recall involves machines running software versions 4.1.2, 4.1.3, and 4.1.4, where the perfusion scan feature may not be available.

The issue affects customers who previously used basic axial perfusion software (versions preceding 4.1.2) without purchasing the helical perfusion license key. These users could not access the basic axial perfusion feature after upgrading to software version 4.1.2.

The affected units were distributed worldwide, including in the United States and numerous other countries. The specific serial numbers for the 30 affected units are listed in the official recall documentation.

The recalled product

Product
Brilliance 64 Computed Tomography X-ray system
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography
Hazard
Affected units
30

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. 728231
  • S/N: 4001
  • 9074
  • 9099
  • 9538
  • 9549
  • 9573
  • 9638
  • 9646
  • 9656
  • 9667
  • 9703
  • 9738
  • 9755
  • 9782
  • 9811
  • 9822
  • 9909
  • 9923
  • 9927

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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