—#128364

Product

Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072485
Affected lot / code info: Syngo RT Therapist (RTT 4.3.SP1) - model no. 08162815 Syngo RT Oncologist (RTO 4.3.SP1) - model no. 10568604 Syngo RT Therapist (RTT 4.3.SP1) for U.S. affected units only: 10010 10046 10586 No Syngo RT Oncologist (RTO 4.3.SP1) listed for U.S.

Why it was recalled

Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand LINAC systems that may experience sporadic system crashes that will cause the inability to unload patient data.

Root cause (FDA determination)

Software design

Action the firm took

In June, 2014, an urgent medical device correction field safety notice of improvement was sent to end users informing them of the product, problem, and action to be taken to avoid the potential safety issue.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: UT, WI, NY

Timeline

Recall initiated: 2014-06-17
Posted by FDA: 2014-08-10
Terminated: 2014-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128364. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.