—#139481

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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K142434
Affected lot / code info: Model Number of device- 10568604, serial numbers: 10206 10337 10338 10100 10289 10197 10131 10179 10184 10158 10235 10236 10080 10296

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.

Root cause (FDA determination)

Software design

Action the firm took

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: marlynne.galloway@siemens.com

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Mail Code: 65-1A, Malvern, Pennsylvania 19355-1418

Distribution

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

Timeline

Recall initiated: 2015-08-11
Posted by FDA: 2015-10-06
Terminated: 2016-12-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139481. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.