Reported Jun 17, 2020 · Terminated
RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can…
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 4.0 to RayStation 5
- Service Pack 2 - Product UsageFor radiation therapy and medical oncology which can also be used to administer treatments
- Lot codes and dates
- Build numbers
4.0.3.44.5.1.144.7.2.54.7.3.134.7.4.44.7.5.44.7.6.75.0.1.115.0.2.35
- Build numbers
- 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Raysearch Laboratories Ab recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.