Recall Z-2812-2015— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2015-08-05, terminated 2016-09-01. It names 5 FDA 510(k) clearances: K103606, K090683, K060226 and 2 more. 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.. Reason: A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-05
- Terminated
- 2016-09-01
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
5 on FDA's record- K103606 — ARTISTE SOLUTION WITH SYS_VB50 UPDATE
- K090683 — SYNGO RT THERAPIST CONNECT
- K060226 — ONCOR EXPRESSION
- K031764 — ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
- K993425 — PRIMUS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
Data sourced from openFDA. This site is unofficial and independent of the FDA.