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Recall Observatory FDA recall evidence

Device product

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

Z-0998-2026

August 27, 2025

Class II

Product summary

Firm
Vision RT Ltd
Event
Event 98236
Status
Ongoing
Classification
Class II
Quantity
56
Official record key
device-enforcement:Z-0998-2026

Official wording

Reason: 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).

Code information: Part Number V000629

Distribution pattern: U.S. and OUS

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).