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PedCAT

CURVEBEAM, LLC · Model 1000-230 · UDI-DI 00863152000317

JAK Prescription

510(k) clearances

5,242

Adverse events (219 deaths)

865

Recalls

162

Facilities

Description

Cone Beam Computed Tomography diagnostic imaging system dedicated to the foot and ankle. Compatible with 230 Volts power outlet. 3D field of view of 20 cm (height) x 35 cm (diameter) accommodates weight bearing, bilateral imaging of both entire feet/ankles. Built-in cushioned seat allows for non-weight bearing imaging. Handlebars assist patients with entry into and exit from device. Scan time is 48 seconds or less. Scans are output as DICOM compatible 3D reconstructions, 0.3 mm multi-planar slices. PedCAT system includes acquisition station and visualization station enabled with CubeVue visualization software.

Recalls

Date	Firm	Reason
2026-08-07	Philips North America Llc	Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
2026-08-07	Philips North America Llc	Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
2026-08-07	Philips North America Llc	Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
2026-08-07	Philips North America Llc	Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
2026-06-26	Philips Healthcare (Suzhou) Co., Ltd.	Potential of failing to trigger clinical scan during Bolus Tracking.
2026-06-11	PHILIPS MEDICAL SYSTEMS	The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result i
2026-06-11	PHILIPS MEDICAL SYSTEMS	The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result i
2026-06-11	PHILIPS MEDICAL SYSTEMS	The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result i
2026-03-26	GE Medical Systems, LLC	GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with
2026-03-26	GE Medical Systems, LLC	GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.