Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1464-2014·Announced 2014-04-23

Philips Ingenuity Core 128 CT Systems Recalled for Software Reconstruction Failures

Philips is recalling 116 Ingenuity Core 128 CT systems worldwide because a software upgrade caused intermittent reconstruction failures.

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 functional software defect (incomplete reconstructions) without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary or functional recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc. is recalling 116 units of the Ingenuity Core 128 Computed Tomography X-ray system. The recall is due to a software issue where reconstructions would intermittently fail to complete after upgrading from version 3.5.4 to 3.5.5.

The affected systems were distributed nationwide in the United States and in numerous countries including Australia, China, France, Germany, India, Japan, and the United Kingdom. The recall is classified as Class II by the FDA.

Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issue. No specific corrective action or consumer steps are detailed in the source text beyond the identification of the defect.

The recalled product

Product: Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Imaging Equipment
Hazard: software-defect
functional-failure
Affected units: 116

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)

System code: 728323
Serial #: 320002
320003
320004
320005
320006
320007
320008
320009
320010
320011
320013
320014
320015
320017
320018
320019
320020
320022
320023

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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