Recall Z-2174-2014— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-05-28, terminated 2015-07-23. It names 4 FDA 510(k) clearances: K072485, K031764, K982502 and 1 more. Product: Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.. Reason: A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-28
- Terminated
- 2015-07-23
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
4 on FDA's record- K072485 — ARTISTE MV SA
- K031764 — ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
- K982502 — GENESIS IMRT LINEAR ACCELERATOR
- K790688 — MEVATRON 67
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
Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.
Reason for recall
A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.