FDA Device recall Z-0984-2015
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software
- FDA Device
- Class II
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class II recall of ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software by Siemens Medical Solutions Usa, citing there may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0984-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-19 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | NY, UT, WI |
Product
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
Reason
There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.
Identifiers
| code_info | Model number: 08139789, serial numbers: 5419, 5784, 5830 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0984-2015%22
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