The Recall Desk
ModerateFDA (Devices)·Z-0548-2016·Announced 2015-12-30

Philips CT System Recall for Missing Perfusion Scan Feature

Philips is recalling 177 Ingenuity Core 128 CT systems because the perfusion scan feature may be unavailable on specific software versions.

What this means for you

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 feature availability issue rather than a physical defect causing injury or death. This aligns with the rubric for moderate severity involving functional limitations or minor issues without reported harm.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 177 units of the Ingenuity Core 128 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 on versions preceding 4.1.2 without purchasing the helical perfusion license key. These customers were unable to 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.

Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software access issue. The recall number is Z-0548-2016.

The recalled product

Product
Ingenuity Core 128 Computed Tomography X-ray system
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography
Hazard
Affected units
177

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. 728323
  • S/N: 30016
  • 32012
  • 32013
  • 32016
  • 32024
  • 32028
  • 32033
  • 32036
  • 32041
  • 32046
  • 32048
  • 32050
  • 32051
  • 32052
  • 32053
  • 32054
  • 32055
  • 32056
  • 32058

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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