Philips CT System Recalled for Software Issues
Philips Medical Systems is recalling Ingenuity Core 128 CT systems due to software issues in version 4.1.6.
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, and the source text does not report any injuries, illnesses, or specific high-risk hazards, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling the Philips Ingenuity Core 128 computed tomography x-ray system. The recall is due to numerous issues related to the Brilliance iCT 4.1.6 software version.
The affected units were distributed to 26 US Government accounts. The source text does not specify the nature of the software issues or any reported injuries or illnesses.
Healthcare facilities should contact Philips Medical Systems for further instructions on how to address the software issues.
The recalled product
- Product
- Philips Ingenuity Core 128 computed tomography x-ray system
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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