Siemens Medical Solutions USA, Inc recalls Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segme…

Recall date

August 11, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0106-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Distribution to states of: MA, MO, OH, PA, UT, and WI.

Why it was recalled

This update is intended to provide a software update for the Syngo RT Oncologist, which is currently running SW version 4.2 or 4.3. The safety-related issues, which were described in the Customer Safety Notice distributed as UFSN-RTT/RTO 4.3 Adaptive Targeting [Auto-registration]. The update contains several important safety and performance fixes.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.