Reported Dec 14, 2016 · Terminated
Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment…
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 · Sveavaegen 9 · Stockholm, N/A · N/A
Is this the product you have?
- Radiation Therapy
- Treatment Planning System Product UsageRayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user
- Lot codes and dates
- Build No"5.0.0.37 , 5.0.1.11 or 5.0.2.35 . Only 5.0.2.35 was distributed in the U.S
- Amount recalled
- 540 units
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
An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Reference as the displayed auxiliary CT set exists in another case, the dose display may be incorrect. When the error occurs, the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. The dose value normally displayed in the upper left corner when pointing in the 2D view may be incorrect or missing.
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.