Reported May 8, 2024 · Ongoing

RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.

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 · Eugeniavagen 18c · Stockholm · N/A

Is this the product you have?

  • RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
Lot codes and dates

4 of 4 products

Products covered by this recall
Model / numberBarcodesProduct as published
0735000201038920210518, 0735000201043320210610, 0735000201044020210916 and 0735000201063120220616
0735000201038907350002010433073500020104400735000201063107350002010433, 07350002010440 and 07350002010631
Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15
Expiration Date: 2027-06-22.
Amount recalled
10 units

This recall covers 12 products

The agency filed one notice per product. You are reading one of them; the other 11 are below.

Where it was sold

  • Nationwide

Why it was recalled

Potential for reported SSD to be too high.

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.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.