The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.

Recall Insight

This FDA Devices action (record #Z-0998-2026) was formally reported on January 14, 2026, with the manufacturer initiating the action on August 27, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Vision RT Ltd is listed as the recalling firm, operating out of London. Federal records indicate 56 units are affected.

The documented reason for this recall is: 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 f… Distribution data in the federal record shows the product reached: U.S. and OUS. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. Because this recall is recent, remedy windows and replacement inventory are most likely still actively available from the firm or retailer. Always cross-check the recall number against the official agency page before relying on any summary.