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Toshiba American Medical Systems Recalls
57 recalls on record · September 5, 2012 to July 4, 2018 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 4, 2018Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and m
Hazard: The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
March 14, 2018Medical DevicesFDA
Toshiba American Medical Systems Inc recalls INFX-8000H Fluoroscopic X-Ray Systems
Hazard: During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
March 14, 2018Medical DevicesFDA
Toshiba American Medical Systems Inc recalls INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
Hazard: During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
March 14, 2018Medical DevicesFDA
Toshiba American Medical Systems Inc recalls INFX-8000C Fluoroscopic X-Ray Systems
Hazard: During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
March 14, 2018Medical DevicesFDA
Toshiba American Medical Systems Inc recalls INFX-8000F Fluoroscopic X-Ray Systems
Hazard: During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
October 25, 2017Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnost
Hazard: During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.
September 20, 2017Medical DevicesFDA
Toshiba American Medical Systems recalls Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceil
Hazard: It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed " System Error (2063)" which required a reboot and loss of the image.
September 6, 2017Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for g
Hazard: The issue was identified as a firmware problem with the generator.
July 19, 2017Medical DevicesFDA
Toshiba American Medical Systems Inc recalls APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
Hazard: When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
July 19, 2017Medical DevicesFDA
Toshiba American Medical Systems Inc recalls APLIO 500 TUS-A500 diagnostic ultrasound system
Hazard: When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
July 19, 2017Medical DevicesFDA
Toshiba American Medical Systems Inc recalls APLIO 300 TUS-A300 diagnostic ultrasound system
Hazard: When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
July 19, 2017Medical DevicesFDA
Toshiba American Medical Systems Inc recalls XARIO 200 TUS-X200 diagnostic ultrasound system
Hazard: When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
July 19, 2017Medical DevicesFDA
Toshiba American Medical Systems Inc recalls XARIO 100 TUS-X100 diagnostic ultrasound system
Hazard: When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
June 7, 2017Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Hazard: It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. This issue occurs when the power for the Angio Workstation is turned on after the power for the Infinix system is turned on.
March 22, 2017Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Toshiba Ultimax DREX-ULT80 X-ray generator
Hazard: It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
March 22, 2017Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Toshiba Kalare DREX-KL80 X-ray generator
Hazard: It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
November 30, 2016Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation a
Hazard: Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system operation.
October 12, 2016Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
Hazard: It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
October 12, 2016Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Hazard: It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
October 12, 2016Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated
Hazard: It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
October 12, 2016Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
Hazard: It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
August 24, 2016Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
Hazard: Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error.
July 27, 2016Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
Hazard: During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.
July 13, 2016Medical DevicesFDA
Toshiba American Medical Systems Inc recalls MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power
Hazard: A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.
May 11, 2016Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acqu
Hazard: Potential degradation of detector performance.
May 4, 2016Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Light
Hazard: Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry.
March 30, 2016Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended
Hazard: When a user performed radiography using the wireless FPD, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. It also indicated to select the "OK" button to re-acquire the image data or to select the¿'Cancel" button to cancel the re-acquisition. As instructed the user selected "OK" and the same message window appeared. This same operation was repeated several times with the identical result - no image. Finally, the user selected "Cancel" and the re-acquisition was terminated.
February 17, 2016Medical DevicesFDA
Toshiba American Medical Systems Inc recalls INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Hazard: When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".
October 21, 2015Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Toshiba Aquilion CT System TSX-303A
Hazard: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
October 21, 2015Medical DevicesFDA
Toshiba American Medical Systems Inc recalls Toshiba Aquilion CT System TSX-302A
Hazard: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.