Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with… — Class II medical device recall Z-0499-2026
Ongoing recall by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, reported 2025-11-19, distributed nationwide. Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could pot
| Recall number | Z-0499-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, Kyoto, Japan |
| Recall initiated | 2025-10-16 |
| Classified | 2025-11-13 |
| Reported by FDA | 2025-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | HT |
| Quantity | 1,766 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04540217014484, 04540217050826 |
| Serial numbers | 0162M42920, 0162M43015, 0162M43016, 0162M43017, 0162M43218, 0162M43518, 0162M43610, 0162M43611, 0162M43612, 0162M43613, 0162M43614, 0162M43615, 0162M43616, 0162M43617, 0162M43618, 0162M43619, 0162M43620, 0162M43916, 0162M44409, 0162M44509, 0162M44510, 0162M45101, 0162M45102, 0162M45118, 0162M45119 and 475 more |
| Model numbers | CH-200, CH-200M |
Product
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 when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system.
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.
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-0499-2026. 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.