Recall Register

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION: FDA recalls

FDA enforcement reports name SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION as the recalling firm in 5 events. The events have 6 product records. The recalls started from 2023 to 2025. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

5 events, newest first.

FDA enforcement events of SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
InitiatedProduct (first record)TypeClassRecordsStatus
16 Oct 2025Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography…DeviceClass II1Ongoing
6 Sep 2024Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.DeviceClass II1Ongoing
6 Sep 2024SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.DeviceClass II2Ongoing
29 Jan 2024Shimadzu, Trinias, Digital Angiography SystemDeviceClass II1Ongoing
10 Apr 2023Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 unitsDeviceClass II1Ongoing

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION: events for each product type
TypeEvents
Device5
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION: events in each class
ClassEvents
Class II5
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
5

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, by the year that the recall started. The largest year is 2024, with 3 events.

Official channels

Cite this page

Recall Register. SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION: FDA recalls. https://recallregister.com/firm/shimadzu-corporation-medical-systems-division/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION have?
Class II: 5 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION?
FDA event 97365, which the firm started on 16 Oct 2025. The first product in the record is: Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography…
How many FDA recalls of SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION have the status Ongoing?
5 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.