FDA recall Z-0998-2026

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

Status

Ongoing

Initiation date

2025-08-27

Report date

2026-01-14

Voluntary/Mandated

FDA Mandated

Location

London, United Kingdom

Primary source

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