ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear a
FDA device recall Z-0984-2015 · posted 2015-03-18 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 3
- Distribution
- US Distribution to the states of UT, WI, and NY.
- Date initiated
- 2014-11-19
- Date posted
- 2015-03-18
- Date terminated
- 2015-04-28
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONCOR EXPRESSION (K060226) | Siemens Medical Solutions USA, Inc. | 2006-03-15 |