North Star Imaging Inc — Class II medical device recall Z-0063-2018
Ongoing recall by North Star Imaging Inc, reported 2017-11-15, distributed in KS, OH, PA. It was discovered a low-level radiation leak that was found on the NSI X-7000 system.
| Recall number | Z-0063-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | North Star Imaging Inc, ROGERS, MN, United States |
| Recall initiated | 2017-08-23 |
| Classified | 2017-11-06 |
| Reported by FDA | 2017-11-15 |
| Distributed | KS, OH, PA |
| Quantity | 3 units |
| Reason classes | packaging |
| Model numbers | X-7000 |
Product
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
Reason for recall
It was discovered a low-level radiation leak that was found on the NSI X-7000 system.
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-0063-2018. 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.