Vision RT AlignRT InBore system recalled for missing laser safety information
What this means
Vision RT identified that instructions for the AlignRT InBore radiation therapy system omitted required information about its six Class 1 lasers and their specifications. The missing details are required by federal laser safety regulations. No injuries have been reported.
- Contact Vision RT for updated Instructions for Use with complete laser safety information
- Review updated documentation before continuing use of the system
The agency's original wording
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0998-2026Want us to check the next one for you?
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