thejoe
Toshiba American Medical Systems Inc
Toshiba American Medical Systems Inc: 56 FDA recall reports
Every medical device recall the FDA has published for Toshiba American Medical Systems Inc. The fault, and how the agency graded it.
56Reports
0Class I
0Ongoing
2018-07-04Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be dam
Z-2315-2018 · Class II · reported 2018-07-04 · Terminated
- Why it was recalled
- 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.
- Product
- Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 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.
- Where it went
- USA (nationwide) Distribution to the states of : CA, CO, DE, GA, HI, IA, ID, IL, IN, MD, MI, MN, MO, NC, ND, NV, OH, OR, PA, SC, SD, TN, TX, VA, WA, WV and WY.
- How much
- 162 units total
INFX-8000C Fluoroscopic X-Ray Systems
Z-0843-2018 · Class II · reported 2018-03-14 · Terminated
- Why it was recalled
- 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.
- Product
- INFX-8000C Fluoroscopic X-Ray Systems
- Where it went
- United States
- How much
- 19 units
INFX-8000F Fluoroscopic X-Ray Systems
Z-0842-2018 · Class II · reported 2018-03-14 · Terminated
- Why it was recalled
- 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.
- Product
- INFX-8000F Fluoroscopic X-Ray Systems
- Where it went
- United States
- How much
- 17 units
INFX-8000H Fluoroscopic X-Ray Systems
Z-0845-2018 · Class II · reported 2018-03-14 · Terminated
- Why it was recalled
- 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.
- Product
- INFX-8000H Fluoroscopic X-Ray Systems
- Where it went
- United States
- How much
- 2 units
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
Z-0844-2018 · Class II · reported 2018-03-14 · Terminated
- Why it was recalled
- 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.
- Product
- INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
- Where it went
- United States
- How much
- 29 units
Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universa
Z-0012-2018 · Class II · reported 2017-10-25 · Terminated
- Why it was recalled
- 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.
- Product
- Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.
- Where it went
- USA (nationwide) Distribution
- How much
- US - 96
Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is inte
Z-3070-2017 · Class II · reported 2017-09-06 · Terminated
- Why it was recalled
- The issue was identified as a firmware problem with the generator.
- Product
- Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular IVR, vascular contrast-enhanced studies support of vascular NR, and general radiography.
- Where it went
- US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA.
- How much
- 18
XARIO 200 TUS-X200 diagnostic ultrasound system
Z-2709-2017 · Class II · reported 2017-07-19 · Terminated
- Why it was recalled
- 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.
- Product
- XARIO 200 TUS-X200 diagnostic ultrasound system
- Where it went
- Nationwide Distribution
- How much
- 1 unit
APLIO 500 TUS-A500 diagnostic ultrasound system
Z-2711-2017 · Class II · reported 2017-07-19 · Terminated
- Why it was recalled
- 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.
- Product
- APLIO 500 TUS-A500 diagnostic ultrasound system
- Where it went
- Nationwide Distribution
- How much
- 307 units
XARIO 100 TUS-X100 diagnostic ultrasound system
Z-2708-2017 · Class II · reported 2017-07-19 · Terminated
- Why it was recalled
- 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.
- Product
- XARIO 100 TUS-X100 diagnostic ultrasound system
- Where it went
- Nationwide Distribution
- How much
- 7 units
APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
Z-2712-2017 · Class II · reported 2017-07-19 · Terminated
- Why it was recalled
- 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.
- Product
- APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
- Where it went
- Nationwide Distribution
- How much
- 28 units
APLIO 300 TUS-A300 diagnostic ultrasound system
Z-2710-2017 · Class II · reported 2017-07-19 · Terminated
- Why it was recalled
- 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.
- Product
- APLIO 300 TUS-A300 diagnostic ultrasound system
- Where it went
- Nationwide Distribution
- How much
- 90 units
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Z-2109-2017 · Class II · reported 2017-06-07 · Terminated
- Why it was recalled
- 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.
- Product
- Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
- Where it went
- US Distribution to the states of :LA, IL, NY, FL, MA, TN, MO, GA, CA, DE, MO, AL, ID, MN, TX, CT, PA, MS, OH, NC, NV, W VA, WA, AR, NJ, MD, OK, IN and NH.
- How much
- US - 70 systems
Toshiba Kalare DREX-KL80 X-ray generator
Z-1397-2017 · Class II · reported 2017-03-22 · Terminated
- Why it was recalled
- It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
- Product
- Toshiba Kalare DREX-KL80 X-ray generator
- Where it went
- USA ( nationwide ) Distribution to the states of : WA, OR, CA, OH, IL, CT, IA, KY, AL, LA, HI, PA, NJ, DE, MN, DC, NY, MI, SC, MD, TN, OK, WI, UT, ID, NV, TX, AL, IN, WV, KS, MO, CO, MT, MS, NC, GA, NH,UT, FL, AZ and ND.
- How much
- 254
Toshiba Ultimax DREX-ULT80 X-ray generator
Z-1398-2017 · Class II · reported 2017-03-22 · Terminated
- Why it was recalled
- It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
- Product
- Toshiba Ultimax DREX-ULT80 X-ray generator
- Where it went
- USA ( nationwide ) Distribution to the states of : WA, OR, CA, OH, IL, CT, IA, KY, AL, LA, HI, PA, NJ, DE, MN, DC, NY, MI, SC, MD, TN, OK, WI, UT, ID, NV, TX, AL, IN, WV, KS, MO, CO, MT, MS, NC, GA, NH,UT, FL, AZ and ND.
- How much
- 254
Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed
Z-0622-2017 · Class II · reported 2016-11-30 · Terminated
- Why it was recalled
- 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.
- Product
- Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
- Where it went
- Nationwide Distribution
- How much
- 291 units
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems
Z-0047-2017 · Class II · reported 2016-10-12 · Terminated
- Why it was recalled
- 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.
- Product
- Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
- Where it went
- US Distribution to the states of: PA, IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.
- How much
- 165
Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
Z-0046-2017 · Class II · reported 2016-10-12 · Terminated
- Why it was recalled
- 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.
- Product
- Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
- Where it went
- US Distribution to the states of: PA, IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.
- How much
- 165
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Z-0048-2017 · Class II · reported 2016-10-12 · Terminated
- Why it was recalled
- 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.
- Product
- Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
- Where it went
- US Distribution to the states of: PA, IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.
- How much
- 165
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
Z-0049-2017 · Class II · reported 2016-10-12 · Terminated
- Why it was recalled
- 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.
- Product
- Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
- Where it went
- US Distribution to the states of: PA, IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.
- How much
- 165
Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
Z-2542-2016 · Class II · reported 2016-08-24 · Terminated
- Why it was recalled
- Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error.
- Product
- Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
- Where it went
- US Distribution
- How much
- 93 units
Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Pl
Z-2188-2016 · Class II · reported 2016-07-27 · Terminated
- Why it was recalled
- 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.
- Product
- Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
- Where it went
- US Distribution to the states of : NC, NY, TX, GA, CA, AZ, IL, FL,MA, MO and DE.
- How much
- 23
MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010
Z-2135-2016 · Class II · reported 2016-07-13 · Terminated
- Why it was recalled
- A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.
- Product
- MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the features of Atlas technology with Open-Bore technology, making patient comfort a priority. To offer an enhanced level of performance, we are crossing over to Toshibas new 3T Conform Technology. Vantage Titan 3T features a patient aperture of 71 cm and Pianissimo noise reduction technology. It comes with a new, fully functional, state-of-the-art interface designed for ease of use.
- Where it went
- US Nationwide Distribution
- How much
- 33 units
Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is design
Z-1607-2016 · Class II · reported 2016-05-11 · Terminated
- Why it was recalled
- Potential degradation of detector performance.
- Product
- Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D images) of the whole human body (including the head). The CT images provide morphological information showing the positional relationships between the lesion and adjacent tissues, while the PET images provide functional information based on the uptake of the injected radioisotope.
- Where it went
- US Distribution to WI and NV.
- How much
- 3 units
Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aqui
Z-1560-2016 · Class II · reported 2016-05-04 · Terminated
- Why it was recalled
- 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.
- Product
- Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
- Where it went
- US in the state Nevada
- How much
- 1 unit
Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-
Z-1175-2016 · Class II · reported 2016-03-30 · Terminated
- Why it was recalled
- 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.
- Product
- Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices.
- Where it went
- Nationwide distribution to PA, UT, FL, NY, LA, WV, NJ, OH, WI and TX.
- How much
- 28
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Z-0752-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- 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".
- Product
- INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
- Where it went
- US Nationwide Distribution to OH and NY
- How much
- 4
Toshiba Aquilion CT System TSX-301C
Z-0016-2016 · Class II · reported 2015-10-21 · Terminated
- Why it was recalled
- If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
- Product
- Toshiba Aquilion CT System TSX-301C
- Where it went
- US Distribution including Puerto Rico
- How much
- 459
Toshiba Aquilion CT System TSX-303A
Z-0018-2016 · Class II · reported 2015-10-21 · Terminated
- Why it was recalled
- If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
- Product
- Toshiba Aquilion CT System TSX-303A
- Where it went
- US Distribution including Puerto Rico
- How much
- 459
Toshiba Aquilion CT System TSX-301A
Z-0014-2016 · Class II · reported 2015-10-21 · Terminated
- Why it was recalled
- If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
- Product
- Toshiba Aquilion CT System TSX-301A
- Where it went
- US Distribution including Puerto Rico
- How much
- 459
Showing the 30 most recent of 56. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls