December 18, 2023

Dec

FDA Recall: Software Error Affecting Image Display, Image Reporting, and Incorrect Image During Clinical Use

December 18, 2023Allison PateNews

Company: Philips North America Llc Date of Enforcement Report: 12/18/2023 Class II PRODUCT The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports,...

FDA Recall: Software Error Affecting Image Display, Image Reporting, and Incorrect Image During Clinical Use

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FDA Recall: Software Error Affecting Image Display, Image Reporting, and Incorrect Image During Clinical Use

Upcoming Public Courses

Corporate Office