Recall Z-0998-2026— Vision RT Ltd
Class II · Ongoing
Class II FDA medical device recall by Vision RT Ltd, initiated 2025-08-27. FDA's recall record names no specific 510(k) clearance for this event. 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: 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)..
- Recalling firm
- Vision RT Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-27
- Firm location
- London, United Kingdom
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.