Vision RT Ltd: Device Recall
Recall #Z-0998-2026 · 08/27/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0998-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Vision RT Ltd
- Status
- Ongoing
- Date Initiated
- 08/27/2025
- Location
- London, United Kingdom
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 56
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).
Product Description
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Distribution Pattern
U.S. and OUS
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.