FDA recall Z-1466-2020

Product

RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system

Reason for recall

There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.

Distribution

The products were distributed to the following US states: TN

Key facts

Status

Terminated

Initiation date

2020-02-20

Report date

2020-03-18

Termination date

2024-11-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stockholm, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1466-2020