4 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
FDA Recall
Completed
·Philips Ultrasound, Inc.·Product code ITX·June 30, 2023
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
FDA Recall
Completed
·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code ITX·March 14, 2025
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, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
FDA Recall
Completed
·Philips North America Llc·Product code JAK·March 29, 2022
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, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
FDA Enforcement
Class II
·Completed·Philips North America Llc·December 27, 2023