The AlignRT InBore system contains six Class 1 lasers which enables… — Class II medical device recall Z-0998-2026
Ongoing recall by Vision RT Ltd, reported 2026-01-14. Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore syst
| Recall number | Z-0998-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Vision RT Ltd, London, United Kingdom |
| Recall initiated | 2025-08-27 |
| Classified | 2026-01-06 |
| Reported by FDA | 2026-01-14 |
| Quantity | 56 |
| Model numbers | V000629 |
Product
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Reason for recall
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).
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-0998-2026. 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.