Philips Ingenuity CT Scanners Recalled for Image Exposure Mislabeling
Philips Medical Systems is recalling 79 Ingenuity CT scanners because they may mislabel the order of image exposures, potentially affecting clinical interpretation.
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 hazard involves a labeling/ordering error that could affect clinical interpretation but does not involve a direct physical injury mechanism or reported illnesses.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling 79 units of the Ingenuity CT, Ingenuity Core, and Ingenuity Core128 Computed Tomography (CT) scanners. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data. The recall covers units distributed in the United States and various countries worldwide.
The recall was initiated because the systems can mislabel the exposure that results in an image in the incorrect order that it was taken by the user. This defect may lead to the misinterpretation of the sequence of images acquired during a scan.
Affected units are distributed in the US states of Arizona, California, Connecticut, Florida, Georgia, Massachusetts, Mississippi, Ohio, Pennsylvania, Texas, and Wyoming, as well as in Australia, Denmark, Finland, France, Germany, India, Ireland, Japan, Malaysia, the Netherlands, New Zealand, Norway, Russia, Slovakia, South Africa, South Korea, Sweden, Switzerland, and the United Kingdom. Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue.
The recalled product
- Product
- The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 79
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 (20)
- Ingenuity CT: 728326 300005
- 300010
- 300012
- 300016
- 300017
- 300019
- 300020
- 300021
- 300028
- 300029
- 300031
- 300032
- 300033
- 300035
- 300037
- 300039
- 300043
- 300047
- 300050
- 300051
Distribution
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