ARTISTE MV System recall: Software Issue
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to…
Why was ARTISTE MV System recalled?
There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model number: 08139789, serial numbers: 5419, 5784, 5830
- Product
- ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 3
- Distribution
- US Distribution to the states of UT, WI, and NY.
- Recall date
- March 25, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)