AlignRT- Intended for prescription use — Class II medical device recall Z-0464-2015
Terminated recall by Vision Rt Inc, reported 2014-12-03, distributed in CA, MN, TX, UT. Potential failure of AlignRT to assert interlock.
| Recall number | Z-0464-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vision Rt Inc, Columbia, MD, United States |
| Recall initiated | 2014-10-15 |
| Classified | 2014-11-25 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2016-05-10 |
| Distributed | CA, MN, TX, UT |
| Countries outside the US | IE |
| Quantity | 7 |
| Serial numbers | 248-052, 248-066, 248-088, 249-0059, 249-0133, 249-0134, 249-0139 |
Product
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
Reason for recall
Potential failure of AlignRT to assert interlock.
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-0464-2015. 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.