Class II — Vision Rt Inc
| Recalling firm | VISION RT LIMITED |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential failure of AlignRT to assert interlock. |
| 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. |
| Quantity | 7 (Six Units distribited in the US and One in OUS.) |
| Distribution | Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland. |
| Initiated | 2014-10-15 |
| Classified | 2014-11-25 |
| Terminated | 2016-05-10 |
| Recall number | Z-0464-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Vision Rt Inc (Z-0464-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69515/
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