Philips Brilliance 16 CT Scanner Recalled for Image Reconstruction Defect
Philips Medical Systems is recalling 192 Brilliance 16 CT scanners because a software upgrade can cause planned anatomy to be cut off in images, potentially requiring a rescan.
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 and the need for a rescan, which is a moderate risk of harm without reported injuries or fatalities.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 192 units of the Brilliance 16 Computed Tomography (CT) X-ray system, Model number 728246. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data. The recall covers units distributed nationwide across numerous US states and territories.
The recall is due to a defect that occurs after upgrading to software 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.
Healthcare facilities and users of these devices should contact Philips Medical Systems for further instructions on how to address the software issue and ensure proper image reconstruction.
The recalled product
- Product
- Brilliance 16, Model number 728246 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
- 192
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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