Philips Spectral CT Software Recalled for Image Processing Defects
Philips Medical Systems is recalling Spectral CT software due to a defect causing issues with filming, saving, and annotating images.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. While the specific health consequences are not detailed in the source text, the defect affects medical imaging software used for diagnostic analysis, fitting the criteria for a high-risk product where injury has not yet been explicitly reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 20 units of Philips Spectral CT Applications software. The software supports viewing and analysis of images at selected energies to provide information about the chemical composition of body materials and contrast agents.
The recall is due to a software defect that causes issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving, and annotating images. The agency has classified this recall as Class II.
The software was distributed in the states of Arkansas, Indiana, Louisiana, Massachusetts, Minnesota, Oregon, and Tennessee. It was also shipped to Belgium, Denmark, France, Germany, Japan, Korea, Switzerland, and the United Kingdom. Affected units are identified by specific code numbers listed in the recall documentation.
The recalled product
- Product
- Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — Software
- Affected units
- 20
Distribution
Part of a larger recall action
This product is one of 2 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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