HIGHFDA DEVICE
Vision RT Recalls AlignRT InBore System Over Laser Omission Hazard
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
Vision RT