Philips Spectral CT software issue causes image mislabeling
A software defect in Philips Spectral CT on Rails affects image labeling, potentially leading to patient misdiagnosis and incorrect treatment. This FDA Class II recall affects one unit distributed across multiple U.S. states and internationally.
- Product
- Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
- Category
- Medical Device
- Distribution
- Distributed nationwide