Food, drugs, devices › SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Device recall: Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4
FDA enforcement event 92391 is a device recall by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION of Kyoto, N/A, initiated 10 Apr 2023 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. 88% of the 917 device enforcement events initiated in 2023 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, N/A, Japan.
Reason for recall
"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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 | 1836 | Class II | Ongoing | 9 Aug 2023 |
Context
Other enforcement events for SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 Oct 2025 | Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The c | Device | Class II | 1 |
| 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 |
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: "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."
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: "U.S. Nationwide distribution."
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.