Vision RT Ltd 2026-01-14 Health serious FDA
Health · FDA · Recall #FDA-Z-0998-2026
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras… Recall
Issued January 14, 2026 · Vision RT Ltd
In January 2026, Vision RT Ltd recalled the The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Vision RT Ltd to arrange your fda mandated. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (FDA Mandated):
Recall details
- Brand
- Vision RT Ltd
- Category
- Health
- Recall date
- January 14, 2026
- Units affected
- Not reported
- Sold at
- U.S. and OUS
- Recall number
- FDA-Z-0998-2026
- Made in
- United Kingdom
- Issuing agency
- FDA
In context
- Vision RT Ltd has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.