Vision RT Ltd: The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.

Hazard

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).

Details from the source

Reason for recall: 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). Distribution: U.S. and OUS Quantity: 56 Lot/code info: Part Number V000629

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.