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Terminated

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.

FDA Recall Z-0106-2016 · Posted 2015-10-06

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2015-08-11
Date Terminated2016-12-07
Product Quantity14

Reason for Recall

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.

Firm Action

The firm, Siemens, sent Recall letters, dated August 2015, that describe the product, the problem, and correction, will be hand-delivered to affected sites at the time the fix is implemented by a Siemens technician. If you have any questions, contact Regulatory Technical Specialist at 610-448-6471 or email: [email protected]

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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