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Brivo 615

GE Hualun Medical Systems Co., Ltd · Model 5376496-15 · UDI-DI 00840682117869

JAK KPS Prescription

510(k) clearances

5,267

Adverse events (219 deaths)

865

Recalls

162

Facilities

Description

TANDEM GANTRY-B615 Medical Device

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.