RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
Check against the official notice below — it lists the full affected range.
RaySearch Laboratories AB is recalling RayStation/RayPlan 9A, Build Number 9.0.0.113, a stand-alone software treatment planning system. The recall affects one system distributed to Tennessee. The problem involves a potential for incorrect propagation of tabletop positions when pitch or roll correction is applied. Although pitch and roll correction itself is not propagated, the presence of non-zero pitch or roll values causes the lateral, longitudinal, and vertical position values that are propagated to become inaccurate.
This software defect could result in patients receiving treatment based on incorrect positioning data. The affected product can be identified by its UDI code 07350002010174. The recall source does not specify a remedy or what actions affected consumers should take.
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 07350002010174
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.