Drug recall

The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient…

FDA recall event 98236 · Class II · Vision RT Ltd

Key facts

Event ID 98236
Recall numbers Z-0998-2026
Recalling firm Vision RT Ltd
Product type Devices
Products The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Classification Class II
Status Ongoing
Voluntary or mandated FDA Requested
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…
Initiation date Aug 27, 2025
Report date Jan 14, 2026
City London
Country United Kingdom
FEI number 3004832819

At a glance

  • 1–9 Products in this recall
  • None FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA drug and product recalls

FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.

Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date:

Browse all FDA drug and product recalls