Vision RT recalled 56 AlignRT InBore systems on August 27, 2025, due to missing safety information in the Instructions for Use. The omission pertains to the identification and characteristics of the system's Class 1 lasers as required by federal regulations. Users must stop using the device immediately and follow manufacturer instructions.
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).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Vision RT Ltd or your healthcare provider for instructions
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The AlignRT InBore system, part number V000629, includes six Class 1 lasers for patient tracking. It was distributed in the U.S. and internationally. The quantity recalled is 56 units.
The recall stems from an omission in the Instructions for Use regarding the identification of the lasers. This defect violates federal regulations under 21 CFR 1040.10(h) and may pose a risk during operation.
Patients and healthcare providers should stop using the AlignRT InBore system immediately. Contact Vision RT Ltd for further instructions.
For more information, call Vision RT Ltd directly or visit their website. Additional details can be found at the FDA recall notice: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0998-2026.
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