Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1874-2016·Announced 2016-06-08

Philips Ingenuity Core 128 CT Systems Recalled for Drive Mapping Issue

Philips Medical Systems is recalling 424 Ingenuity Core 128 CT systems because the system may not map the Varian drive after a user logout and login.

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, and the source text does not report any illnesses, injuries, or deaths. The hazard is a functional software issue (drive mapping) rather than a direct physical safety risk like fire or shock, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 424 units of the Ingenuity Core 128 Computed Tomography X-ray Systems. The recall was initiated after the firm became aware of a problem where the system may not map the Varian drive after a CT user logout and login.

The affected systems were distributed worldwide, including nationwide in the United States and in numerous international countries. The specific model number is 728323, and the recall covers a specific range of serial numbers listed in the official FDA documentation.

Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue. The source text does not specify a particular action for consumers, as these are medical devices used in clinical settings.

The recalled product

Product: Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Computed Tomography (CT) Scanner
Hazard: software-defect
functional-failure
Affected units: 424

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 (1)

Model No. 728323

Distribution

Distributed nationwide across the United States.

The notice also names 45 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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