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Shimadzu Medical Systems
Shimadzu Medical Systems: 26 FDA recall reports
Every medical device recall the FDA has published for Shimadzu Medical Systems. The fault, and how the agency graded it.
26Reports
0Class I
10Ongoing
2026-06-10Most 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.
Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40
Z-2294-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
- Product
- Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Radiography System RADspeed Pro: UD150B-40 / UD150V-40 / UD150L-40 / UD150L-40E/D150BC-40 / D150VC-40 / D150LC-40 / D150LC-40E/D150BC-41 / D150VC-41 / D150LC-41; Digital Radiography System RADspeed safire: UD150B-40 / D150BC-40; Radiography System RADspeed fit: N/A (Integrated in the system); X-RAY R/F SYSTEM SONIALVISION safire17:UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION safire Plus: UD150B-40 / D150BC-4;0 X-RAY R/F SYSTEM SONIALVISION safire: UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION VERSA: UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM FLUOROspeed 300:UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM SONIALVISION G4:D150BC-40S; X-RAY R/F SYSTEM FLUOROspeed X1:D150BC-40S
- Where it went
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, The Bahamas, China, Denmark, Haiti.
- How much
- 3487 units
MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Z-0869-2022 · Class II · reported 2022-04-13 · Ongoing
- Why it was recalled
- It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
- Product
- MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
- Where it went
- U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, and WV. O.U.S.: N/A
- How much
- 12 systems
MODEL: X-RAY TV SYSTEM SONIALVISION G4
Z-0868-2022 · Class II · reported 2022-04-13 · Ongoing
- Why it was recalled
- It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
- Product
- MODEL: X-RAY TV SYSTEM SONIALVISION G4
- Where it went
- U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, and WV. O.U.S.: N/A
- How much
- 176 systems
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
Z-0867-2022 · Class II · reported 2022-04-13 · Ongoing
- Why it was recalled
- It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
- Product
- MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
- Where it went
- U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, and WV. O.U.S.: N/A
- How much
- 25 systems
Digital Angiography System Bransist safire Generator Model D150GC-40
Z-0654-2022 · Class II · reported 2022-03-09 · Ongoing
- Why it was recalled
- Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
- Product
- Digital Angiography System Bransist safire Generator Model D150GC-40
- Where it went
- U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.
- How much
- 18
Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
Z-0655-2022 · Class II · reported 2022-03-09 · Ongoing
- Why it was recalled
- Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
- Product
- Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
- Where it went
- U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.
- How much
- 28 systems
MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiogr
Z-0556-2021 · Class II · reported 2020-12-16 · Ongoing
- Why it was recalled
- The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
- Product
- MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
- Where it went
- US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.
- How much
- 22 units
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan
Z-0534-2021 · Class II · reported 2020-12-16 · Ongoing
- Why it was recalled
- There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.
- Product
- Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
- Where it went
- US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, ND, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI.
- How much
- 115 units
Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usag
Z-0554-2021 · Class II · reported 2020-12-16 · Ongoing
- Why it was recalled
- The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
- Product
- Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.
- Where it went
- US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.
- How much
- 7 units
Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: inte
Z-0555-2021 · Class II · reported 2020-12-16 · Ongoing
- Why it was recalled
- The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
- Product
- Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
- Where it went
- US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.
- How much
- 23 units
Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Us
Z-2591-2020 · Class II · reported 2020-07-22 · Completed
- Why it was recalled
- The DAP meters were found to be outside of tolerance.
- Product
- Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.
- Where it went
- US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.
- How much
- 3 devices
Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended
Z-2060-2018 · Class II · reported 2018-06-20 · Terminated
- Why it was recalled
- When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.
- Product
- Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.
- Where it went
- US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.
- How much
- 17
Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG3
Z-0918-2017 · Class II · reported 2017-01-04 · Terminated
- Why it was recalled
- Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions.
- Product
- Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.
- Where it went
- US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.
- How much
- 13 units
Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
Z-0917-2017 · Class II · reported 2017-01-04 · Terminated
- Why it was recalled
- Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions.
- Product
- Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
- Where it went
- US: TX, NY, SD, PA, MD, OH, IA, IN, MT, IL, FL, SC, OR, CA, AR, GA, CT, NV, PA, NE, WA
- How much
- 39 units
X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray t
Z-1585-2016 · Class II · reported 2016-05-04 · Terminated
- Why it was recalled
- Report of unintentional movement of table to reverse tilting.
- Product
- X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography
- Where it went
- Nationwide Distribution
- How much
- 185 units
Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a t
Z-0451-2016 · Class II · reported 2015-12-30 · Terminated
- Why it was recalled
- The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.
- Product
- Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
- Where it went
- US Distribution and Internationally to Canada
- How much
- 297 units
Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
Z-0251-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- The C-arm may interfere with the table top under certain circumstances.
- Product
- Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
- Where it went
- Worldwide Distribution. US (Texas, Wisconsin, Ohio, and Connecticut), Iran, India, Saudi Arabia, Serbia, Thailand, Germany, Croatia, Turkey, Lebanon, Korea, and China.
- How much
- 26 units total (4 units in US)
Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for ra
Z-1569-2014 · Class II · reported 2014-05-14 · Terminated
- Why it was recalled
- Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.
- Product
- Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.
- Where it went
- Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.
- How much
- 685 units total (14 units in US)
Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order
Z-1150-2014 · Class II · reported 2014-03-12 · Terminated
- Why it was recalled
- Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 and MUX-100H) because the connecting metal plate which connects the main chassis and the column of MUX-100 may crack.
- Product
- Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency
- Where it went
- USA Nationwide Distribution
- How much
- 56 units
Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general
Z-1369-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and CXDI-55G. As a result of Shimadzu's investigation, there is a potential risk for screws becoming loose inside the Shimadzu Mobile X-ray systems.
- Product
- Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .
- Where it went
- US Nationwide Distribution
- How much
- 200 units
0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-
Z-0262-2013 · Class II · reported 2012-11-14 · Terminated
- Why it was recalled
- Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
- Product
- 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
- Where it went
- US Nationwide Distribution
- How much
- 288 units
0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usag
Z-0263-2013 · Class II · reported 2012-11-14 · Terminated
- Why it was recalled
- Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
- Product
- 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
- Where it went
- US Nationwide Distribution
- How much
- 133 units
0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radi
Z-0265-2013 · Class II · reported 2012-11-14 · Terminated
- Why it was recalled
- Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
- Product
- 0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
- Where it went
- US Nationwide Distribution
- How much
- 3 units
R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK
Z-0261-2013 · Class II · reported 2012-11-14 · Terminated
- Why it was recalled
- Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
- Product
- R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography.
- Where it went
- US Nationwide Distribution
- How much
- 308 units
0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiograp
Z-0264-2013 · Class II · reported 2012-11-14 · Terminated
- Why it was recalled
- Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
- Product
- 0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
- Where it went
- US Nationwide Distribution
- How much
- 5 units
R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364D
Z-0260-2013 · Class II · reported 2012-11-14 · Terminated
- Why it was recalled
- Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
- Product
- R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting device for X-ray Radiography.
- Where it went
- US Nationwide Distribution
- How much
- 665 units
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.
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