7 results
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Sources: EU EUDAMED, US FDA
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Status: Completed
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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
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.
FDA Enforcement
Class II
·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·October 30, 2024
PTS Panels CHOL+GLU Test Strips (REF 1765)
FDA Enforcement
Class III
·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·September 21, 2022
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
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.
FDA Recall
Completed
·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code LCP·September 18, 2024
PTS Panels CHOL+GLU Test Strips (REF 1765)
FDA Recall
Completed
·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code CGA·August 16, 2022