FDA recall Z-1930-2019

Product

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 Use: software system designed for treatment planning and analysis of radiation therapy

Reason for recall

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

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2017-11-20

Report date

2019-07-10

Termination date

2023-08-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1930-2019