Philips Brilliance BigBore CT Scanner Recalled for Image Reconstruction Error
Philips is recalling 24 Brilliance BigBore CT scanners because a software upgrade can cause planned anatomy to be cut off in gated helical scan images.
What this means for you
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 technical image reconstruction error that may require a rescan, with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 24 units of the Brilliance BigBore Radiology CT (Model number 728244). These computed tomography X-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data.
The recall is due to a software issue that occurs after upgrading to version 3.6.7 via FCO72800643. During the reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue specifically affects gated CT helical reconstruction that is not planned at the iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.
The affected units were distributed nationwide in the United States, including the District of Columbia and Puerto Rico. No specific instructions for consumers are provided in the source text, but the recall indicates that rescans may be necessary if image quality is compromised.
The recalled product
- Product
- Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed Tomography X-ray systems 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 Medical Systems (Cleveland) Inc
- Affected units
- 24
Distribution
Part of a larger recall action
This product is one of 7 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.
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