Class II — Vision RT Ltd
| 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 | Ongoing |
| Reason | Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56). |
| Product | The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement. |
| Quantity | 56 |
| Distribution | U.S. and OUS |
| Initiated | 2025-08-27 |
| Classified | 2026-01-06 |
| Recall number | Z-0998-2026 |
| Initiation | FDA Mandated |
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 Ltd (Z-0998-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98236/
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