Food, drugs, devices › SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Device recall: Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The c
FDA enforcement event 97365 is a device recall by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION of Kyoto, initiated 16 Oct 2025 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, Kyoto, Japan.
Reason for recall
"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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography… | 1,766 devices | Class II | Ongoing | 19 Nov 2025 |
Context
Other enforcement events for SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 Sep 2024 | Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the followin | Device | Class II | 1 |
| 6 Sep 2024 | SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examina | Device | Class II | 2 |
| 29 Jan 2024 | Shimadzu, Trinias, Digital Angiography System | Device | Class II | 1 |
| 10 Apr 2023 | Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 | Device | Class II | 1 |
All 5 events for SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.