Canon Medical System, USA, INC.: 16 recalls on record

Recalls filed with 1 agency: FDA (16).

First recall on record: July 17, 2019. Most recent: September 2, 2026.

Risk classification: Class II: 16

Most recent recalls

DateAgencyProduct
September 2, 2026FDAAlphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiograp…Z-3014-2026
January 21, 2026FDAVANTAGE GALAN 3T Model MRT-3020/MEXL-3020Z-1017-2026
November 5, 2025FDAVANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.Z-0327-2026
November 13, 2024FDACartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic i…Z-0284-2025
June 19, 2024FDAMRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vanta…Z-2041-2024
March 13, 2024FDAMRI system: Vantage Elan, Model: MRT-2020Z-1249-2024
March 13, 2024FDAMRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550Z-1248-2024
March 13, 2024FDAVantage Titan, Model: MRT-1504Z-1250-2024
February 28, 2024FDAThe device is an X-ray system that is capable of radiographic and fluoroscopic studies an…Z-1154-2024
February 28, 2024FDAThe INFX-8000F is designed to take advantage of the latest technological innovations to r…Z-1155-2024
July 6, 2022FDASystem: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INF…Z-1289-2022
December 9, 2020FDACAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angio…Z-0532-2021
April 22, 2020FDACanon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1Z-1726-2020
April 22, 2020FDACanon Aquilion Prime SP, Model TSX-303BZ-1724-2020
April 22, 2020FDACanon Aquilion Prime, Model TSX-303AZ-1723-2020
July 17, 2019FDARadrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005…Z-1958-2019

Questions about this company

How many recalls does Canon Medical System, USA, INC. have?
Recalert has 16 U.S. recalls on record for Canon Medical System, USA, INC., published between July 17, 2019 and September 2, 2026.
What was the most recent Canon Medical System, USA, INC. recall?
FDA recall Z-3014-2026, published September 2, 2026: Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indica…
Which agencies have handled Canon Medical System, USA, INC. recalls?
Canon Medical System, USA, INC. appears as the recalling firm in recalls from: FDA (16).

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