Toshiba American Medical Systems

57 recalls β€’ β€’ Categories: Diagnostic Equipment, Other Medical Devices, Implants & Prosthetics, Surgical Instruments

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.

Jan 4, 2018 Diagnostic Equipment Nationwide View Details β†’

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.

Dec 29, 2017 Other Medical Devices View Details β†’

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.

Dec 29, 2017 Other Medical Devices View Details β†’

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.

Dec 29, 2017 Other Medical Devices View Details β†’

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.

Sep 12, 2017 Diagnostic Equipment Nationwide View Details β†’

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.

Mar 23, 2017 Other Medical Devices Nationwide View Details β†’

The issue was identified as a firmware problem with the generator.

Mar 15, 2017 Diagnostic Equipment View Details β†’

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.

May 1, 2017 Diagnostic Equipment Nationwide View Details β†’

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.

May 1, 2017 Diagnostic Equipment Nationwide View Details β†’

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.

May 1, 2017 Diagnostic Equipment Nationwide View Details β†’

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.

May 1, 2017 Diagnostic Equipment Nationwide View Details β†’

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.

Oct 25, 2016 Other Medical Devices Nationwide View Details β†’

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.

Apr 25, 2016 Diagnostic Equipment Nationwide View Details β†’

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.

Feb 24, 2016 Other Medical Devices View Details β†’

A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.

Apr 14, 2016 Diagnostic Equipment Nationwide View Details β†’

Potential degradation of detector performance.

Apr 24, 2016 Implants & Prosthetics View Details β†’

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.

Apr 12, 2016 Diagnostic Equipment View Details β†’

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 theΒΏ'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.

Jan 14, 2016 Other Medical Devices Nationwide View Details β†’

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".

Aug 14, 2015 Other Medical Devices Nationwide View Details β†’

The table base rotational brake that holds the table top may not always be engaged when any force or side impact is applied to the table top.

Mar 11, 2015 Surgical Instruments Nationwide View Details β†’

Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curve generated based on some of those parameters.

Nov 5, 2014 Diagnostic Equipment Nationwide View Details β†’

Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curve generated based on some of those parameters.

Nov 5, 2014 Diagnostic Equipment Nationwide View Details β†’

Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.

May 12, 2014 Other Medical Devices Nationwide View Details β†’

Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions used for contrast study may not start.

Oct 1, 2013 Other Medical Devices Nationwide View Details β†’

Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System. When the system is used in combination with either the QD Head Coil (MJQH-142A) or the Large Knee SPEEDER (MJAJ-182A), SAR values lower than the actual SAR values may be displayed on the operating monitor.

Oct 28, 2013 Other Medical Devices Nationwide View Details β†’

The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly

Aug 5, 2013 Diagnostic Equipment Nationwide View Details β†’

The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly

Aug 5, 2013 Diagnostic Equipment Nationwide View Details β†’

The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly

Aug 5, 2013 Diagnostic Equipment Nationwide View Details β†’

The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly

Aug 5, 2013 Diagnostic Equipment Nationwide View Details β†’

Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also heated after a few seconds or more. This occurs when the Automatic Exposure Function (AEC) function is used. As a result, a radiographic tube current exceeding the set value flows and a brighter image than expected is acquired.

Apr 3, 2013 Diagnostic Equipment Nationwide View Details β†’

Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. The startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. It has been determined that this may potentially cause damage to the system.

Dec 11, 2012 Diagnostic Equipment Nationwide View Details β†’

It was found that there is a problem with the LCD monitor used in the console. The LCD monitor may become blank during use. Specifically, the backlight of the LCD monitor may turn off while the system is in use, causing the LCD monitor to become blank. However, the other parts of the system continue to operate normally, and the risk of a serious health hazard is therefore very low. The LCD Moni

Oct 15, 2012 Other Medical Devices Nationwide View Details β†’

Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.

Nov 8, 2012 Diagnostic Equipment Nationwide View Details β†’

The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.

May 13, 2008 Diagnostic Equipment Nationwide View Details β†’

The systems all have a similar table control board. It has been found that this board may cause the table position to be incorrect if the table cradle is moved manually. This is referred to as "Free" mode in the operation manuals. If this error does occur it is possible that the patient could be scanned at an incorrect position.

Feb 27, 2008 Diagnostic Equipment Nationwide View Details β†’

1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco

Jul 13, 2009 Diagnostic Equipment Nationwide View Details β†’