Philips Brilliance CT Big Bore Oncology Software Recall
Philips is recalling 33 Brilliance CT Big Bore Oncology systems due to a software defect that may cause planned anatomy to be cut off in gated helical CT images.
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. The hazard involves a software defect that may result in incomplete images, potentially requiring a rescan, but no injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 33 units of the Brilliance CT Big Bore Oncology, Model number 728243. 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. The specific serial numbers for the 33 affected units are listed in the recall documentation. Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issue.
The recalled product
- Product
- Brilliance CT Big Bore Oncology, Model number 728243 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
- 33
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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