Philips CT Scanner Software Recall for Performance Issues
Philips is recalling Ingenuity Core CT scanners due to software issues in versions v4.1.3, v4.1.4, and v4.1.5 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 injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 276 units of the Ingenuity Core Model No. 728321 CT scanners. The recall is due to software issues in versions v4.1.3, v4.1.4, and v4.1.5 that could affect the performance of the equipment.
The affected products were shipped to 46 US states and numerous countries worldwide. The source text does not specify the exact nature of the performance issues or report any specific injuries or illnesses associated with the defect.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the software issue. Consumers should not use the affected equipment until it has been serviced or updated by the manufacturer.
The recalled product
- Product
- Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — CT Scanner
- Hazard
- Affected units
- 276
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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