Reported Jul 10, 2019 · Terminated

RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9)…

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

RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6)
Intended Usesoftware system designed for treatment planning and analysis of radiation therapy

Lot codes and dates: Software versions
3.5.0.16
3.5.1.6
4.0.0.14
4.0.1.4
4.0.2.9
4.0.3.4
4.5.0.19
4.5.1.14
4.5.2.7
4.7.0.15
4.7.1.10
4.7.2.5
4.7.3.13
4.7.4.4
4.7.5.4
4.9.0.42
5.0.0.37
5.0.1.11
5.0.2.35
5.0.3.17
6.0.0.24
6.1.0.26
6.1.1.2 and 6.2.0.7
Amount recalled: 744

When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong

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

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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