SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro — Class II medical device recall Z-2654-2017
Terminated recall by Shimadzu Medical Systems Usa Com, reported 2017-07-05, distributed nationwide. Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
| Recall number | Z-2654-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimadzu Medical Systems Usa Com, Torrance, CA, United States |
| Recall initiated | 2017-05-23 |
| Classified | 2017-06-29 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2019-10-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP |
| Quantity | 1,673 units |
| Reason classes | packaging |
| Serial numbers | 0162M4501 |
Product
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
Reason for recall
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
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-2654-2017. 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.