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.
Reported: March 25, 2015 Initiated: November 19, 2014 #Z-0984-2015
Product Description
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 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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 3
- Distribution
- US Distribution to the states of UT, WI, and NY.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 3.
Why was this product recalled? ▼
There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2015. Severity: Moderate. Recall number: Z-0984-2015.
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