The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0549-2016·Announced 2015-12-30

Philips Ingenuity CT System Recall for Perfusion Software Access Issue

Philips is recalling 31 Ingenuity 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, but the source text describes a software access limitation rather than a physical defect causing injury or death, fitting the criteria for a moderate severity issue.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 31 units of the Ingenuity CT Computed Tomography X-ray system. The recall is due to a software issue where the perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4.

The issue affects customers who previously used the basic axial perfusion software (versions preceding 4.1.2) without purchasing the helical perfusion license key. These customers 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, Australia, and numerous other countries. The recall is classified as Class II by the FDA. Customers should contact Philips Medical Systems for assistance regarding the software issue.

The recalled product

Product
Ingenuity CT Computed Tomography X-ray system
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography (CT)
Hazard
Affected units
31

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. 728326
  • S/N: 2
  • 1234
  • 30005
  • 30009
  • 30017
  • 30018
  • 30020
  • 30023
  • 30028
  • 30031
  • 30034
  • 30037
  • 31001
  • 32065
  • 32067
  • 52030
  • 52031
  • 52044
  • 52049

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 →

Related recalls

Same manufacturer · Philips Medical Systems (Cleveland) Inc

See all →

Same hazard · software defect

See all →

Similar recalls