Shimadzu Medical Systems recalls

Shimadzu Medical Systems appears in 26 official U.S. recall notices indexed by RecallRadar, most recently on 2026-06-10.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recall notices	26
Published	2012-11-14 to 2026-06-10
By agency	FDA Device (26)
By classification	Class II (26)
By status	terminated (15), ongoing (10), completed (1)
Distribution named in notices	AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, US, WA, WI, WV

Recalls

Digital Angiography System Trinias:UD150G-40 / D150GC-40
FDA Device · Class II · 2026-06-10 · Shimadzu Medical Systems
Reason: Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
FDA Device · Class II · 2022-04-13 · Shimadzu Medical Systems
Reason: 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.
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
FDA Device · Class II · 2022-04-13 · Shimadzu Medical Systems
Reason: 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.
MODEL: X-RAY TV SYSTEM SONIALVISION G4
FDA Device · Class II · 2022-04-13 · Shimadzu Medical Systems
Reason: 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.
Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
FDA Device · Class II · 2022-03-09 · Shimadzu Medical Systems
Reason: 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.
Digital Angiography System Bransist safire Generator Model D150GC-40
FDA Device · Class II · 2022-03-09 · Shimadzu Medical Systems
Reason: 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.
Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac a…
FDA Device · Class II · 2020-12-16 · Shimadzu Medical Systems
Reason: 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 le…
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device…
FDA Device · Class II · 2020-12-16 · Shimadzu Medical Systems
Reason: 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…
Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoro…
FDA Device · Class II · 2020-12-16 · Shimadzu Medical Systems
Reason: 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 le…
MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiograph…
FDA Device · Class II · 2020-12-16 · Shimadzu Medical Systems
Reason: 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 le…
Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be use…
FDA Device · Class II · 2020-07-22 · Shimadzu Medical Systems
Reason: The DAP meters were found to be outside of tolerance.
Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in…
FDA Device · Class II · 2018-06-20 · Shimadzu Medical Systems
Reason: 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 Gener…
Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
FDA Device · Class II · 2017-01-04 · Shimadzu Medical Systems
Reason: 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.
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-r…
FDA Device · Class II · 2017-01-04 · Shimadzu Medical Systems
Reason: 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.
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…
FDA Device · Class II · 2016-05-04 · Shimadzu Medical Systems
Reason: Report of unintentional movement of table to reverse tilting.
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 digi…
FDA Device · Class II · 2015-12-30 · Shimadzu Medical Systems
Reason: The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.
Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table
FDA Device · Class II · 2015-11-18 · Shimadzu Medical Systems
Reason: The C-arm may interfere with the table top under certain circumstances.
Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f
FDA Device · Class II · 2014-05-14 · Shimadzu Medical Systems
Reason: Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.
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 pa…
FDA Device · Class II · 2014-03-12 · Shimadzu Medical Systems
Reason: 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.
Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the h…
FDA Device · Class II · 2013-06-12 · Shimadzu Medical Systems
Reason: 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…
0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-…
FDA Device · Class II · 2012-11-14 · Shimadzu Medical Systems
Reason: 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)…
R-30H , Diagnostic X-Ray Beam-Limiting Device
FDA Device · Class II · 2012-11-14 · Shimadzu Medical Systems
Reason: 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)…
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 c…
FDA Device · Class II · 2012-11-14 · Shimadzu Medical Systems
Reason: 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)…
R-20J , Diagnostic X-Ray Beam-Limiting Device
FDA Device · Class II · 2012-11-14 · Shimadzu Medical Systems
Reason: 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)…
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…
FDA Device · Class II · 2012-11-14 · Shimadzu Medical Systems
Reason: 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)…
0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray sy…
FDA Device · Class II · 2012-11-14 · Shimadzu Medical Systems
Reason: 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)…