# FDA recall Z-0998-2026

> **Vision RT Ltd** · Class II · device recall initiated 2025-08-27.

## Product

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).

## Distribution

U.S. and OUS

## Key facts

- **Recall number:** Z-0998-2026
- **Recalling firm:** Vision RT Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-27
- **Report date:** 2026-01-14

- **Voluntary/Mandated:** FDA Mandated
- **Location:** London, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0998-2026

## Citation

> AI Analytics. FDA recall Z-0998-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0998-2026. Source: US FDA. Licensed CC0.

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