FDA Enforcement Class II Ongoing

The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliability in their layout tasks. The integrated Class 2 green aiming laser system enhances visibility and accuracy, even on uneven surfaces. It is ideal for general and specialty contractors, the RTS873 streamlines layout processes, reduces rework, and enhances overall productivity.

Recall: Z-1661-2025 · Reported May 7, 2025

Enforcement

Recall Number
Z-1661-2025
Event ID
96736
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Trimble Ab
Voluntary / Mandated
FDA Mandated
Initial Notification
Letter
Report Date
May 7, 2025
Initiation Date
March 26, 2025
Classification Date
April 28, 2025
Address
Rinkebyvagen 17, Danderyd, N/A, Sweden

Description

The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliability in their layout tasks. The integrated Class 2 green aiming laser system enhances visibility and accuracy, even on uneven surfaces. It is ideal for general and specialty contractors, the RTS873 streamlines layout processes, reduces rework, and enhances overall productivity.

Reason

An issue has been identified in the production of the RTS873 robotic total stations that may result in the green aiming laser output power being above its laser safety Class 2 classification.

Code Info

Trimble RTS873 instruments produced from October 2023 to February 12, 2025.

Distribution

US and OUS (South Korea and United Kingdom).

Quantity

127