The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | August 27, 2025 |
| Reported | January 14, 2026 |
| Recalling firm | Vision RT Ltd |
| Country / region | United Kingdom U.S. and OUS |
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).
Affected products
- The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
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