Shimadzu Corporation Medical Systems Division

JapanFDA applicant, unverified FDA FEI 3002808139

Devices: 2
Registrations: FDA
FDA recalls: 66 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA FEI, FDA recalls

What Shimadzu Corporation Medical Systems Division makes

Shimadzu Corporation Medical Systems Division manufactures the Trinias, a cardiac monitoring system designed for continuous, real-time electrocardiogram (ECG) recording, and the SET-5002, a portable ECG device for ambulatory patient monitoring.

The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.

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

Catalogue2

Newest first, rows 1-2 of 2

Trinias Ref K221922 Open recall

Active Regimes: CE MDD 510(k) Registry: 510(k) Class:II
Set-5002 Ref K240827

Active Regimes: 510(k) Registry: 510(k) Class:II

Company details

FDA FEI number: 3002808139
Address: 1,NISHINOKYO KUWABARA-CHO, KYOTO

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 6 recalls initiated by Shimadzu Corporation Medical Systems Division, the earliest on 2023-04-10 and the most recent on 2025-10-16. By recorded status: 6 ongoing. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, mechanical integrity 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 0
2019 0
2020 0
2021 0
2022 0
2023 1
2024 4
2025 1
2026 0

2025
- 16 Oct 2025 Z-0499-2026 Class II Ongoing Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID,…
  Full distribution text
  Worldwide - U.S. 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, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SM, SC, SD, TN, TX, VA, WA, and WI. The countries of Dominica, Grand Bahama, Haiti, and Saint Maarten.
2024
- 6 Sep 2024 Z-0139-2025 Class II Ongoing If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button. Distribution: US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN. Submission number: K123508
- 6 Sep 2024 Z-0316-2025 Class II Ongoing X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination. Distribution: US Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX,…
  Full distribution text
  US Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX, TN, CO.
  Submission number: K190373
- 6 Sep 2024 Z-0317-2025 Class II Ongoing X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination. Distribution: US Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX,…
  Full distribution text
  US Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX, TN, CO.
  Submission number: K191877
- 29 Jan 2024 Z-1292-2024 Class II Ongoing Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function. Distribution: US Nationwide distribution in the states of OH. Submission number: K123508
2023
- 10 Apr 2023 Z-2270-2023 Class II Ongoing Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to eliminate the risk of the device falling. Distribution: U.S. Nationwide distribution.

Frequently asked questions

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

The registry currently lists 2 devices for Shimadzu Corporation Medical Systems Division. Devices recorded under merged duplicate company entries are counted once.

Which registries list Shimadzu Corporation Medical Systems Division's devices?

Among its 2 most recently registered devices, Shimadzu Corporation Medical Systems Division has devices listed in FDA 510(k) (2 devices).

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

Among its 2 most recently registered devices, the classes recorded for Shimadzu Corporation Medical Systems Division's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Shimadzu Corporation Medical Systems Division?

FDA recall records list 6 recalls initiated by Shimadzu Corporation Medical Systems Division, the most recent initiated on 16 Oct 2025. 6 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 Corporation Medical Systems Division in the registry?

The most recently registered devices listed for Shimadzu Corporation Medical Systems Division include Trinias and SET-5002.

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