Philips Ingenuity CT Systems Recalled for Drive Mapping Issue
Philips is recalling 215 Ingenuity CT systems because they may fail to map the Varian drive after a user logs out and back in.
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 deaths, indicating a moderate risk level.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 215 Ingenuity Computed Tomography X-ray Systems. The recall is due to a software issue where the system may not map the Varian drive after a CT user logs out and logs back in.
The affected units were distributed worldwide, including in the United States and numerous international countries. The specific model number is 728326, and the recall covers a specific list of serial numbers.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 215
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model No. 728326
Distribution
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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