The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0019-2018·Announced 2017-10-25

Philips Brilliance iCT CT Scanner Recall for Data Reconstruction Failure

Philips is recalling Brilliance iCT CT scanners because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patients to be rescanned.

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 defect resulting in the need for rescans rather than a direct physical hazard or reported injury. This aligns with the 'Moderate' criteria for low-risk issues or voluntary precautionary measures where no harm is reported.

Plain-English summary

Philips Electronics North America Corporation is recalling 606 units of the Philips Healthcare Brilliance iCT computed tomography (CT) x-ray systems. These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. The recall involves units running software version 4.16 that were distributed nationwide in the United States.

The recall is due to a software defect that occurs during bolus tracking procedures. In affected cases, no images are generated when the scan is completed, and the raw data file is not available for offline reconstruction. This issue is caused by a discrepancy between the calculated reconstruction length and the actual scan length, which results in the inability to reconstruct the raw data.

The primary consequence of this defect is that the operator may choose to rescan the patient to obtain the necessary images. No injuries or illnesses have been reported in the source text. Consumers and healthcare facilities should contact Philips for further instructions regarding the affected software version.

The recalled product

Product
Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are 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 Electronics North America Corporation
Category
Medical Device — Imaging Equipment
Hazard
Affected units
606

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)

  • Software version 4.16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Philips Electronics North America Corporation 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 →

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