Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 10/14/2015
Class lI:

PRODUCT

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.
Recall Number Z-0106-2016

REASON
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.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 8/11/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
14

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

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