Agency classClass IIOur severity:Moderate FDA (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.

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 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: software-defect
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 →

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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