Vision RT recalls AlignRT InBore systems due to missing laser safety instructions in the product manual, which could lead to improper use. Affected units have part number V000629.
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).
Vision RT is recalling its AlignRT InBore system because the safety instructions for the six Class 1 lasers were omitted from the product manual. This omission could lead to improper use if users don't know the laser safety requirements.
The system uses six Class 1 lasers to track patient movement. Without proper safety instructions, users might not understand the laser safety requirements, potentially leading to improper use.
Users of the AlignRT InBore system for medical procedures are affected. Patients and medical staff who use the system without the updated safety instructions are at risk of improper laser use.
Check for the part number V000629 on the AlignRT InBore system. The system is designed for medical procedures and may be used in healthcare settings.
Check if the product manual includes the required laser safety information as per FDA regulations.
The recall is for missing safety instructions, not an immediate hazard. Class 1 lasers are low-risk but require proper use instructions.
Check for part number V000629 on the AlignRT InBore system.
Review the safety instructions to ensure they include the required laser safety information.
We’ve drafted a message you can send Vision RT to request your refund or repair — edit it as you like.
Subject: Recall Z-0998-2026 — Vision RT Vision RT Hello, I own a Vision RT that is covered by recall Z-0998-2026 from Vision RT. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
