Reported Jul 1, 2020 · Ongoing

RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs)…

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 standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
Lot codes and dates
    • Software versions 8.0.0.61
    • 8.0.1.10
    • 8.1.0.47
    • 8.1.1.8
    • 8.1.2.5
    • 9.0.0.113
    • 9.1.0.933 and 9.2.0.483
Amount recalled
12

Why it was recalled

It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:52 PM UTC

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