FDA Medical devices recall ·
The AlignRT InBore system contains six Class 1 lasers which enables the… recall
- Recall number
- Z-0998-2026
- Date
- (initiated August 27, 2025)
- Company / brand
- Vision RT Ltd
Dove House, London, United Kingdom - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 56
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Why was it 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).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Part Number V000629
Distribution
U.S. and OUS
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0998-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.