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Canon Medical System, USA, INC.

Canon Medical System, USA, INC. Recalls

All product recalls associated with Canon Medical System, USA, INC..

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1361–1380 of 3680 recalls

Canon Vantage Galan 3T (Canon) – Flame Retardancy Problem (2021)

Fire/Burn Risk

The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

High

FDAMay 21, 2021Nationwide• Canon Medical System, USA, INC.

Toshiba Vantage Tiitan 1.5T (Canon) – Flame Retardancy Risk (2021)

Fire/Burn Risk

The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

High

FDAMay 21, 2021Nationwide• Canon Medical System, USA, INC.

Canon Vantage Tiitan 1.5T (Canon) – Flame Retardancy Issue (2021)

Fire/Burn Risk

The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

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High

FDAMay 21, 2021Nationwide• Canon Medical System, USA, INC.

PowerPICC Catheter Kit (Bard) – Guidewire Mismatch (2021)

Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.

Moderate

FDAMay 19, 2021Nationwide• Bard Access Systems Inc.

DigitalDiagnost 4 System (Philips) – Table Height Error (2021)

Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

High

FDAMay 19, 2021Nationwide• Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany

PowerPICC Catheter (Bard) – Micro-Introducer Issue (2021)

Catheter kits contained the incorrect micro-introducers.

Moderate

FDAMay 19, 2021CT, GA, MA +7 more• Bard Access Systems Inc.

Ventec VOCSN Ventilator (Ventec) – Component Failure Risk (2021)

Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy.

Moderate

FDAMay 10, 2021Nationwide• Ventec Life Systems, Inc.

Corin TriFit CF (Corin) – Stem Labeling Mixup (2021)

Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.

Moderate

FDAMay 6, 2021Nationwide• Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom

Corin TriFit TS (Corin) – Stem Labeling Mixup (2021)

Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.

Moderate

FDAMay 6, 2021Nationwide• Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom

Synapse Cardiovascular Software (Fujifilm) – Patient ID Reuse (2021)

Laceration Risk

Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence

Moderate

FDAApr 30, 2021Nationwide• Fujifilm Medical Systems U.S.A., Inc.