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FDA (Device enforcement)Recalled 2020-02-20closedclass ii

RAYSEARCH LABORATORIES AB: RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system

Is my product affected?

RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system

  • UPC 07350002010266

Check against the official notice below — it lists the full affected range.

What happened

RaySearch Laboratories AB is recalling RayStation/RayPlan 9B, Build Number 9.1.0933, a standalone software treatment planning system. The recall was issued because of a potential error in how the software propagates tabletop positions when pitch or roll correction is applied. Specifically, even though pitch and roll corrections themselves are not propagated, non-zero pitch or roll values cause the lateral, longitudinal, and vertical position values that are propagated to be calculated incorrectly.

One system with this software was distributed to Tennessee. The record does not specify a remedy or provide instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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 07350002010266

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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