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Open, Classified

The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.

FDA Recall Z-0998-2026 · Posted 2026-01-07

Recalling FirmVision RT Ltd
Recall StatusOpen, Classified
Product CodeIWE
Date Initiated2025-08-27
Product Quantity56

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).

Firm Action

Vision RT wrote to inform customers of an omission that they have identified in the Instructions for Use for AlignRT InBore systems. This notification contained information for users of AlignRT InBore systems on the content omitted and how to access the corrected Instructions for Use.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

U.S. and OUS

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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