Philips Brilliance 64 CT Scanner Recalled for Image Reconstruction Errors
Philips is recalling 283 Brilliance 64 CT scanners because a software update can cause planned anatomy to be cut off in images, potentially requiring a rescan.
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, and the hazard is a software defect that may require a rescan rather than a direct physical injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling 283 units of the Brilliance 64 CT Model number 728231. These are 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.
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. Healthcare facilities should contact Philips Medical Systems for further instructions on how to address the software issue.
The recalled product
- Product
- Brilliance 64 CT Model number 728231 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
- 283
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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