—#139329

Product

ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031764, K060226, K090683, K103606, K993425
Affected lot / code info: ARTISTE - 08139789 ONCOR Avantgarde - 05863472 ONCOR Impression Plus - 05857912 ONCOR Expression 07360717 PRIMUS - K993425 PRIMUS Plus 04504200 Syngo RT Therapist - 08162815 serial numbers: 5177 3761 3981 3998 5096 70-4161 3354 10570 10793 10794 10796 10795 10798 10814 10792 5300 10046 10549 10687 3624 5350 5784 10586 5830 10010 5419

Why it was recalled

A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

Siemens sent Notification letters to affected customers. The letter identified the affected product, problem and actions to be taken. The letter advise customers that the software fix was rolled out to address multiple safety issues.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution and US Nationwide

Timeline

Recall initiated: 2015-08-05
Posted by FDA: 2015-09-24
Terminated: 2016-09-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139329. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.