Philips Ingenuity CT Software Recall for Performance Issues
Philips Medical Systems is recalling 205 Ingenuity CT units 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 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 issues that could affect performance, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 205 units of the Ingenuity CT Model No. 728326. 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 45 U.S. states and 59 countries. The source text does not specify the exact nature of the performance issues or any reported injuries or illnesses.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the software issues. Consumers should not use the affected equipment until the issue is resolved.
The recalled product
- Product
- Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — CT Scanner
- Affected units
- 205
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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