Philips Ingenuity CT Software Recall for Performance Issues
Philips is recalling Ingenuity Core128 CT scanners due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.
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 hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity rating involving potential performance issues without confirmed harm.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 380 units of the Ingenuity Core128 CT scanner, Model No. 728323. The recall is due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect the performance of the equipment.
The affected products were shipped to 47 U.S. states and numerous countries worldwide. The specific serial numbers for the affected units are listed in the official recall documentation.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the software issues. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — CT Scanner
- Affected units
- 380
Distribution
Part of a larger recall action
This product is one of 6 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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