Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2116-2016·Announced 2016-07-06

Philips Brilliance 64 CT Scanner Recall for Image Artifacts

Philips is recalling 94 Brilliance 64 CT scanners due to intermittent swirl-like ring artifacts on images, which may require patient rescans.

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 hazard is limited to image quality issues requiring rescans rather than direct physical injury or death, fitting the moderate severity criteria for low-risk operational defects.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 94 Brilliance 64 Computed Tomography (CT) X-ray systems. The recall affects systems running software version 3.5.4 that have exhibited intermittent swirl-like ring artifacts on reconstructed images.

The affected units were distributed nationwide in the states of California, Florida, Idaho, Kansas, Michigan, New York, Ohio, and Texas. The specific serial numbers for the affected units are listed in the official recall documentation.

If the artifacts prevent the images from being used for interpretation, a patient rescan may be required. Healthcare facilities should contact Philips Medical Systems for further instructions on resolving the issue.

The recalled product

Product: Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles…
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Imaging Equipment
Hazard: image-artifact
rescan-required
Affected units: 94

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)

Brilliance 64: System Code #728231 Serial numbers: 9847
9936
9937
9963
10067
10146
10155
10181
10184
10189
10191
10216
10240
10292
10768
10769
10770
10771
10772
10773

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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Same hazard · image artifact