AlignRT is a video-based three-dimensional — Class II medical device recall Z-0934-2015
Terminated recall by Vision Rt Inc, reported 2015-01-14, distributed nationwide. Potential use error when the external Gate Controller is turned ON after the Vision RT software has been ope
| Recall number | Z-0934-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vision Rt Inc, Columbia, MD, United States |
| Recall initiated | 2014-11-11 |
| Classified | 2015-01-07 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2016-05-11 |
| Distributed | Nationwide (US) |
| Quantity | 55 |
| Reason classes | software |
Product
AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
Reason for recall
Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
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-0934-2015. 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.