Kyoto, N/A, Japan
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls
5 recalls recorded since 2018, most recently on 16 October 2025. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)5
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 October 2025
- Reason
- 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, 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,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0499-2026
- 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
Ongoing Class II Medical devices
- Recall started
- 6 September 2024
- Reason
- 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, TN, CO.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0316-2025, Z-0317-2025
- SONIALVISION 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.
- The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography
Ongoing Class II Medical devices
- Recall started
- 6 September 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0139-2025
- Trinias 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 genera
Ongoing Class II Medical devices
- Recall started
- 29 January 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1292-2024
- Shimadzu, Trinias, Digital Angiography System
Ongoing Class II Medical devices
- Recall started
- 10 April 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2270-2023
- Over-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 units
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.