United StatesThe AlignRT InBore system (Part Number V000629), which contains six Class 1 lasers used by the system’s cameras to track patient position and movement, is being recalled; 56 units were distributed in the U.S. and internationally. Vision RT Ltd is notifying customers because the Instructions for Use omitted information identifying the lasers and their characteristics as required by 21 CFR 1040.10(h) via conformance with IEC 60825-1 Ed. 3 (FDA Laser Notice 56).
What's being recalled
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Recalling firm: Vision RT Ltd, London, United Kingdom.
How to identify it
Part Number V000629
The 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).
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. and OUS
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)