Integrated Gate Controller PCB — Class II medical device recall Z-0065-2019
Terminated recall by Vision RT Ltd, reported 2018-10-10, distributed nationwide. RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
| Recall number | Z-0065-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vision RT Ltd, London, United Kingdom |
| Recall initiated | 2018-08-24 |
| Classified | 2018-10-03 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2022-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, CA, CH, CN, DE, DK, ES, FI, GB, HR, IL, IN, IT, JP, KR, LT, MA, MY, NO, PL, PT, SE, SG, TH, TR, TW, VN |
| Quantity | 690 systens |
| Serial numbers | 248-010, 248-013, 248-016, 248-021, 248-022, 248-030, 248-038, 248-041, 248-042, 248-048, 248-054, 248-063, 248-064, 248-069, 248-070, 248-071, 248-072, 248-076, 248-080, 248-083, 248-084, 248-085, 248-087, 249-0003, 249-0004 and 475 more |
| Model numbers | V000172 |
Product
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The 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. Part number: V000172
Reason for recall
RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
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-0065-2019. 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.