Reported Jun 17, 2020 · Terminated
RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used…
Raysearch Laboratories Ab
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: RAYSEARCH LABORATORIES AB · Sveavagen 9 · Stockholm, N/A · N/A
Is this the product you have?
RayStation 6UDI # 07350002010013 -
- Product UsageFor radiation therapy and medical oncology which can also be used to administer treatments
- Lot codes and dates
- UDI # 07350002010013
- Build number6.0.0.24
- Amount recalled
- N/A
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
Why it was recalled
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
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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