Vision RT Ltd: Medical Device Recall in 2026 - (Recall #: Z-0998-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 27, 2025

Date Posted: January 14, 2026

Recall Number: Z-0998-2026

Event ID: 98236

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).

Status: Ongoing

Product Quantity: 56

Code Information:

Part Number V000629

Distribution Pattern:

U.S. and OUS

Voluntary or Mandated:

FDA Mandated