Vision RT Ltd recalls The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras t
- Recalling company
- Vision RT Ltd
- 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
- 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).
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 27, 2025
- Reported
- Jan 14, 2026
- Distribution
- U.S. and OUS
- Status
- Ongoing
- Quantity
- 56
- Lot / codes
- Part Number V000629
- Company location
- London
- Recall type
- FDA Mandated
- Recall number
- Z-0998-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0998-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.