—#131894

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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060226
Affected lot / code info: Model number: 08139789, serial numbers: 5419, 5784, 5830

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: US Distribution to the states of UT, WI, and NY.

Timeline

Recall initiated: 2014-11-19
Posted by FDA: 2015-03-18
Terminated: 2015-04-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131894. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.