Philips IQon Spectral CT Software Defect Recall
Philips is recalling 24 IQon Spectral CT systems due to a software defect that causes issues with filming, saving, and annotating 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, and the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall involving a software defect.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 24 IQon Spectral CT systems. 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 affected software was distributed in the United States in Arkansas, Indiana, Louisiana, Massachusetts, Minnesota, Oregon, and Tennessee. It was also shipped to Belgium, Denmark, France, Germany, Japan, Korea, Switzerland, and the United Kingdom.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- Product
- IQon Spectral CT is a Computed Tomography X-Ray System 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
- Hazard
- Affected units
- 24
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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