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Shimadzu Medical Systems

Also registered as Shimadzu Corporation Medical Systems

Country not established

Devices
91
FDA recalls
266 ongoing since 2021 (10 open in total)
4 open since before 2021

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Shimadzu Medical Systems makes

Shimadzu Medical Systems manufactures diagnostic imaging equipment, including linear and convex ultrasound systems like the SHIMASONIC series, whole-body X-ray CT scanners such as the SCT-7000TX, and mobile X-ray systems like the MU125M. Their portfolio also includes high-voltage X-ray generators (XUD150K, XUD150B), MRI systems (SMT-50X/H, SMT-50A), and image amplifiers (IA-12VMA series). Additional ultrasound devices include the SHIMASONIC SDU-350 and diagnostic systems like the SARANO and ECHO VIEW.

The company’s devices are regulated under FDA 510(k) clearance, spanning Class I and Class II medical device classifications. Their imaging systems are listed in the FDA’s 510(k) registry, reflecting compliance with U.S. regulatory requirements. The manufacturer operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue91

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FDA recalls26

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 26 recalls initiated by Shimadzu Medical Systems, the earliest on 2011-10-28 and the most recent on 2026-04-20. By recorded status: 10 ongoing, 15 terminated and 1 with another status. The reasons filed fall into these groups: electrical or power, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 1
  • 2019 1
  • 2020 4
  • 2021 2
  • 2022 3
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 1

14 initiated before 2017

Showing the 10 most recent of 26 recalls.

  • 2026

    • 20 Apr 2026 Z-2294-2026 Class II Ongoing Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID,…
      Full distribution text 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.
      Submission numbers: K062360, K123508, K152244, K203535, K221922, K233722

  • 2022

    • 10 Jan 2022 Z-0867-2022 Class II Ongoing 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. Distribution: 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,…
      Full distribution text 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
      Submission number: K191877
    • 10 Jan 2022 Z-0868-2022 Class II Ongoing 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. Distribution: 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,…
      Full distribution text 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
      Submission number: K142341
    • 10 Jan 2022 Z-0869-2022 Class II Ongoing 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. Distribution: 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,…
      Full distribution text 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
      Submission number: K190373

  • 2021

    • 16 Dec 2021 Z-0654-2022 Class II Ongoing 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. Distribution: U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided. Submission number: K062360
    • 16 Dec 2021 Z-0655-2022 Class II Ongoing 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. Distribution: U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided. Submission number: K123508

  • 2020

    • 18 Nov 2020 Z-0554-2021 Class II Open since 2020 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. Distribution: US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT. Submission number: K062360
    • 18 Nov 2020 Z-0555-2021 Class II Open since 2020 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. Distribution: US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT. Submission number: K123508
    • 18 Nov 2020 Z-0556-2021 Class II Open since 2020 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. Distribution: US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT. Submission number: K943545
    • 9 Nov 2020 Z-0534-2021 Class II Open since 2020 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. Distribution: US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, ND, NE,…
      Full distribution text 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.
      Submission number: K080701
Show the 25 most recent of 26 recalls

  • 2019

    • 4 Nov 2019 Z-2591-2020 Class II Completed The DAP meters were found to be outside of tolerance. Distribution: US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign…
      Full distribution text US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.
      Submission number: K123508

  • 2018

    • 12 Jan 2018 Z-2060-2018 Class II Terminated 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. Distribution: US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ. Submission number: K052500

  • 2016

    • 20 Nov 2016 Z-0917-2017 Class II Terminated 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. Distribution: US: TX, NY, SD, PA, MD, OH, IA, IN, MT, IL, FL, SC, OR, CA, AR, GA, CT, NV, PA, NE, WA Submission number: K142341
    • 20 Nov 2016 Z-0918-2017 Class II Terminated 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. Distribution: US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.
    • 31 Mar 2016 Z-1585-2016 Class II Terminated Report of unintentional movement of table to reverse tilting. Distribution: Nationwide Distribution

  • 2015

    • 10 Nov 2015 Z-0451-2016 Class II Terminated The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly. Distribution: US Distribution and Internationally to Canada Submission number: K080701
    • 30 Sep 2015 Z-0251-2016 Class II Terminated The C-arm may interfere with the table top under certain circumstances. Distribution: Worldwide Distribution. US (Texas, Wisconsin, Ohio, and Connecticut), Iran, India, Saudi Arabia, Serbia, Thailand,…
      Full distribution text Worldwide Distribution. US (Texas, Wisconsin, Ohio, and Connecticut), Iran, India, Saudi Arabia, Serbia, Thailand, Germany, Croatia, Turkey, Lebanon, Korea, and China.
      Submission number: K963888

  • 2014

    • 3 Apr 2014 Z-1569-2014 Class II Terminated Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances. Distribution: Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka,…
      Full distribution text Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.
      Submission number: K052500

  • 2013

    • 15 Nov 2013 Z-1150-2014 Class II Terminated 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. Distribution: USA Nationwide Distribution Submission number: K001517
    • 18 Mar 2013 Z-1369-2013 Class II Terminated 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. Distribution: US Nationwide Distribution Submission number: K080701

  • 2011

    • 28 Oct 2011 Z-0260-2013 Class II Terminated 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. Distribution: US Nationwide Distribution Submission number: K090578
    • 28 Oct 2011 Z-0261-2013 Class II Terminated 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. Distribution: US Nationwide Distribution Submission number: K101036
    • 28 Oct 2011 Z-0262-2013 Class II Terminated 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. Distribution: US Nationwide Distribution Submission number: K001517
    • 28 Oct 2011 Z-0263-2013 Class II Terminated 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. Distribution: US Nationwide Distribution Submission number: K041763
    • 28 Oct 2011 Z-0264-2013 Class II Terminated 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. Distribution: US Nationwide Distribution Submission number: K090268

Frequently asked questions

How many devices does Shimadzu Medical Systems have in the registry?

The registry currently lists 91 devices for Shimadzu Medical Systems. Devices recorded under merged duplicate company entries are counted once.

Which registries list Shimadzu Medical Systems's devices?

Among its 50 most recently registered devices, Shimadzu Medical Systems has devices listed in FDA 510(k) (50 devices).

What risk classes do Shimadzu Medical Systems's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Shimadzu Medical Systems's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Shimadzu Medical Systems?

FDA recall records list 26 recalls initiated by Shimadzu Medical Systems, the most recent initiated on 20 Apr 2026. 10 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Shimadzu Medical Systems in the registry?

The most recently registered devices listed for Shimadzu Medical Systems include SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM, SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX, SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K and SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B.

Generated automatically from registry data and not verified by a human reviewer.