Philips IQon Spectral CT Software Recall for Image Misrepresentation
Philips is recalling 63 IQon Spectral CT systems due to software errors that may cause image misrepresentation or failure to generate 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 3/5 (High).
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 involves a medical device with software errors that may lead to incorrect treatment or image misrepresentation, which poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 63 IQon Spectral CT systems (Model 728332) equipped with software version 4.7.2. The recall is due to software errors that may result in the misrepresentation of CT spectral images or incorrect treatment. Additionally, the software errors may cause a partial set of images to be displayed or prevent the system from generating CT images entirely.
The affected units were distributed domestically and internationally. The recall covers specific serial numbers listed in the agency's records, ranging from 860008 to 890002. No specific dates of distribution or installation are provided in the source text.
Healthcare facilities should contact Philips Medical Systems (Cleveland) Inc to arrange for the necessary software updates or repairs to resolve these issues. Users should verify their equipment's serial number against the provided list to determine if their system is affected.
The recalled product
- Product
- IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 63
Distribution
Distribution scope not specified by the agency.
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