The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Reported: January 14, 2026 Initiated: August 27, 2025 #Z-0998-2026
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.
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).
Details
- Recalling Firm
- Vision RT Ltd
- Units Affected
- 56
- Distribution
- U.S. and OUS
- Location
- London
Frequently Asked Questions
What product was recalled? ▼
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.. Recalled by Vision RT Ltd. Units affected: 56.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 14, 2026. Severity: Moderate. Recall number: Z-0998-2026.
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