Over-Head Ceiling Tube Support — Class II medical device recall Z-2270-2023
Ongoing recall by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, reported 2023-08-09, distributed nationwide. Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is
| Recall number | Z-2270-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, Kyoto, N/A, Japan |
| Recall initiated | 2023-04-10 |
| Classified | 2023-07-31 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 1,836 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04540217031436, 04540217062782 |
| Serial numbers | 0162M42920, 0162M43015, 0162M43016, 0162M43017, 0162M43218, 0162M43518, 0162M43610, 0162M43611, 0162M43612, 0162M43614, 0162M43615, 0162M43616, 0162M43617, 0162M43620, 0162M43916, 0162M44409, 0162M44509, 0162M44510, 0162M45101, 0162M45118, 0162M45119, 0162M45120, 0162M45121, 0162M45122, 0162M45123 and 475 more |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2270-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.