Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0178-2016·Announced 2015-11-04

Philips Recalls Ingenuity Flex CT Systems Due to X-ray Measurement Error

Philips Medical Systems is recalling 67 Ingenuity Flex CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

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. The source text describes a measurement error causing image artifacts but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a defect without reported harm.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 67 units of the Ingenuity Flex Computed Tomography (CT) X-ray system. These devices are intended to produce cross-sectional images of the body. The recall covers units distributed nationwide in the United States and in numerous countries worldwide, including Albania, Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Russia, and the United Kingdom.

The firm discovered that the affected systems produce Ring/Dot artifacts due to an X-ray measurement error. This defect may affect the quality of the images produced by the device. The recall includes specific model and serial numbers, which are listed in the official recall documentation.

Healthcare facilities and consumers who possess these devices should contact Philips Medical Systems for instructions on how to resolve the issue. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recalled product

Product: Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Imaging Equipment
Hazard: measurement-error
image-artifact
Affected units: 67

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. 728317
S/N: 1
78807
260002
260003
340002
340003
345001
345002
345003
345004
345005
345006
345007
345010
345012
345013
345014
345016
345017

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

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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