FDAFDA · Food and drugs·Recall number Z-0998-2026
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Published January 14, 2026 · Recall initiated: August 27, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
FDA Mandated
Recall details
- Manufacturer
- Vision RT Ltd
- Distributor
- U.S. and OUS
- Lot
- Part Number V000629
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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