—#132485

Product

Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS 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: K142434
Affected lot / code info: model # 08162815, serial #s 10010, 10046, 10586

Why it was recalled

Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying this offset can lead to patient mistreatment. Cone Beam imaging is not affected by this problem.

Root cause (FDA determination)

Software Design Change

Action the firm took

A customer advisory notice, dated January 2, 2015, was sent to end users which identified the product, problem, and action to be taken. It was recommended that customers use only manual registration with the 6 degrees of freedom option disabled, which provides the correct offset values. A software update will be deployed once a solution is available.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: UT, WI, NY

Timeline

Recall initiated: 2015-01-02
Posted by FDA: 2015-01-26
Terminated: 2015-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132485. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.