Shimadzu X-ray High Voltage Generator Model No — Class II medical device recall Z-0918-2017
Terminated recall by Shimadzu Medical Systems, reported 2017-01-04, distributed in AZ, CA, FL, LA, NJ, SC, WA. Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil
| Recall number | Z-0918-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimadzu Medical Systems, Torrance, CA, United States |
| Recall initiated | 2016-11-20 |
| Classified | 2016-12-23 |
| Reported by FDA | 2017-01-04 |
| Terminated | 2017-12-11 |
| Distributed | AZ, CA, FL, LA, NJ, SC, WA |
| Quantity | 13 units |
| Reason classes | packaging |
| Serial numbers | 3M5249D1C013, 3M5249D22013, 3M5249D29002, 3M5249D2A004, 3M5249D2C004, 3M5249D31009, 3M5249D32012, 3M5249D33003, 3M5249D34001, 3M5249D35002, 3M5249D37006, 3M5249D41006, 3M5249D46003 |
| Model numbers | UD150B-40 |
Product
Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.
Reason for recall
Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions.
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-0918-2017. 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.