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TOSHIBA SCANNER

CANON INC. · Model TSX-201A · UDI-DI 04987670100604

JAK

510(k) clearances

5,242

Adverse events (219 deaths)

865

Recalls

162

Facilities

Description

This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSHIBA SCANNER. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now CT SCANNER .

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.