RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
Check against the official notice below — it lists the full affected range.
RaySearch Laboratories AB has recalled RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, a stand-alone software treatment planning system. The software has a defect where applying pitch or roll correction can cause incorrect propagation of tabletop position values. Specifically, when pitch or roll correction is applied, the lateral, longitudinal, and vertical values that are propagated become inaccurate, even though the pitch and roll correction itself is not propagated. One system with UDI 07350002010235 was distributed to Tennessee.
The recall record does not specify a remedy or instructions for affected consumers regarding what action they should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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 Quantity: 1 system in the U.S. Lot/code info: UDI 07350002010235
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.