Z-0984-2015Class II

ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV...

Name: Z-0984-2015 ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-11-19
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-11-19 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of 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... on 2014-11-19. FDA classified it as Class II and gives the reason as "There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0984-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-19
Posted: 2015-03-18
Terminated: 2015-04-28
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.
Root cause tag: software
FDA root cause: Software design
Action: Siemens Planned Action: 1. Providing recommendations for user actions in terms of routine dosimetric quality control checks for any IMRT treatment at very high dose rates (Multiple X) as well as for mARC treatments. 2. Software update for the Function Controller #3, which controls parts of the beam generation. This software update enables the correct switching between Pulse Forming Network (PFN) and reduced Pulse Forming Network (iPFN) in pause state, to reduce the dark current during the movement as much as possible. This software will be installed by a Siemens service representative. 3. Siemens will contact the user to make an appointment to implement the modification system at a date and time when the system will be available. These corrections shall be made free of charge. The deployment of the permanent correction shall be completed by July 1, 2015. For further questions please call (610) 219-6300.
Quantity in commerce: 3
Distribution: US Distribution to the states of UT, WI, and NY.
Product codes and lots: Model number: 08139789, serial numbers: 5419, 5784, 5830

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0984-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0984-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-18

Product code IYE

K060226Class IIOncor ExpressionSiemens Medical Solutions USA, Inc. / cleared 2006-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)