Philips Brilliance 64 CT Systems Recalled for Image Reconstruction Failure
Philips Electronics North America Corporation is recalling 606 Brilliance 64 CT systems in the US because a software defect prevents image reconstruction after certain scans.
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 does not report any hospitalizations, injuries, or illnesses, only a functional defect requiring a rescan. This aligns with the 'Moderate' criteria for low-risk issues without reported harm.
Plain-English summary
Philips Electronics North America Corporation is recalling 606 units of the Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed, in the United States. The affected systems are equipped with software version 4.16. 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.
The recall is due to a software defect that can occur during a bolus tracking procedure. In these instances, no images are generated when the scan is completed, and the raw data file is not available for offline reconstruction. This 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 operator may choose to rescan the patient if this issue occurs. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Philips Healthcare Brilliance 64 System, 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
- 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.
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