Home / Brands / Canon Medical System, USA
Canon Medical System, USA Recalls
49 recalls on record · September 12, 2018 to February 4, 2026 · Medical Devices
Recalls by year
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 17, 2021Medical DevicesFDA
Canon Medical System, USA, INC. recalls System INFX-8000V
Hazard: The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
December 16, 2020Medical DevicesFDA
Canon Medical System, USA, INC. recalls Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cro
Hazard: A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium.
December 9, 2020Medical DevicesFDA
Canon Medical System, USA, INC. recalls CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: I
Hazard: There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in a delay with procedure and/or potential damage to the patients blood vessels due to removal without visibility.
September 2, 2020Medical DevicesFDA
Canon Medical System, USA, INC. recalls System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Hazard: During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired.
June 17, 2020Medical DevicesFDA
Canon Medical System, USA, INC. recalls Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluo
Hazard: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
June 17, 2020Medical DevicesFDA
Canon Medical System, USA, INC. recalls Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluo
Hazard: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
June 17, 2020Medical DevicesFDA
Canon Medical System, USA, INC. recalls Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluo
Hazard: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
April 22, 2020Medical DevicesFDA
Canon Medical System, USA, INC. recalls Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
Hazard: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
April 22, 2020Medical DevicesFDA
Canon Medical System, USA, INC. recalls Canon Aquilion Precision, Model TSX-304A
Hazard: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
April 22, 2020Medical DevicesFDA
Canon Medical System, USA, INC. recalls Canon Aquilion Prime SP, Model TSX-303B
Hazard: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
April 22, 2020Medical DevicesFDA
Canon Medical System, USA, INC. recalls Canon Aquilion Prime, Model TSX-303A
Hazard: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
April 22, 2020Medical DevicesFDA
Canon Medical System, USA, INC. recalls Canon Aquilion One Vision, Model TSX-301C
Hazard: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
April 22, 2020Medical DevicesFDA
Canon Medical System, USA, INC. recalls Canon Aquilion Premium, Model TSX-301B
Hazard: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
April 22, 2020Medical DevicesFDA
Canon Medical System, USA, INC. recalls Canon Aquilion One, Model TSX-301A
Hazard: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
April 22, 2020Medical DevicesFDA
Canon Medical System, USA, INC. recalls Canon Aquilion Lightning, Model TSX-036A
Hazard: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
November 20, 2019Medical DevicesFDA
Canon Medical System, USA, INC. recalls Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used
Hazard: Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.
July 17, 2019Medical DevicesFDA
Canon Medical System, USA, INC. recalls Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-
Hazard: software malfunction; It was found when a user performs radiography using the wireless flat panel detector (FPD), a message window displays on the monitor stating image transmission was not completed and there was no image available. It also showed the "OK" button to reacquire image data from the FPD, and the "Cancel" button to cancel the acquisition . When the user selects the "OK" button, the same message window appears. This prompted the user to repeat the same operation several times and finally select the "Cancel" button to quit the reacquistion mode.
October 31, 2018Medical DevicesFDA
Canon Medical System, USA, INC. recalls Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cro
Hazard: When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be lower than the actual SAR value. The actual applied SAR values may exceed the FIRST LEVEL CONTROLLED OPERATING MODE.
September 12, 2018Medical DevicesFDA
Canon Medical System, USA, INC. recalls DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Hazard: It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not completed and there was no image. It also showed the OK button to reacquire image data form the FPD, and the Cancel button to cancel the reacquisition. When the operator selects the OK button, the same message window appears. The operator then repeated the same operation several times and finally selected the Cancel button to quit the reacquisition mode.