Philips IQon Spectral CT Recalled for Image and Scan Errors
Philips is recalling 35 IQon Spectral CT systems due to software issues causing rescans, incorrect scan locations, or misrepresentation of image results.
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 and involves a risk of harm (misrepresentation of image results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 35 IQon Spectral CT systems equipped with software version 4.7.0. The recall is due to multiple issues that have caused the device to result in CT rescans, incorrect scan location, or misrepresentation of image results.
The affected systems are distributed worldwide, including in the United States (AR, IN, LA, MA, MN, OR, TN, and TX) and in Australia, Belgium, Denmark, France, Germany, Israel, Japan, Republic of Korea, Poland, Portugal, Slovenia, Switzerland, Thailand, and the United Kingdom. Specific system serial numbers are listed in the recall documentation.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issues. Patients who have had scans on these systems should consult their healthcare provider regarding the potential impact on their diagnostic results.
The recalled product
- Product
- IQon Spectral CT with software version 4.7.0 Product Usage: The 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. This devic
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 35
Distribution
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