Reported Mar 25, 2015 · Terminated
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 51 Valley Stream Pkwy · Malvern, PA · 19355-1406
Is this the product you have?
- 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.
- Lot codes and dates
- Model number08139789
- serial numbers
541957845830
- Amount recalled
- 3
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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