Brand
Vision RT
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Vision RT and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-01-14FDA-DeviceClass IICheck AlignRT InBore documentation for laser details
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).
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