Canon Medical System, USA, INC.: Medical Device Recalls in 2020

According to to data from the FDA, there were 14 medical device recalls made by Canon Medical System, USA, INC. in 2020. See the details of the recalls below.

You can see similar recalls for other firms.

• Canon Aquilion One Vision, Model TSX-301C
• Canon Aquilion Prime SP, Model TSX-303B
• Canon Aquilion Precision, Model TSX-304A
• Canon Aquilion One, Model TSX-301A
• Canon Aquilion Prime, Model TSX-303A
• Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
• Canon Aquilion Premium, Model TSX-301B
• Canon Aquilion Lightning, Model TSX-036A
• System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
• Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
• Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
• Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
• Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
• CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.