Official recall record
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-08-27
- Country of alert
- United Kingdom
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Vision RT Ltd
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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