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

RAYSEARCH LABORATORIES AB: RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system

Is my product affected?

RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system

  • UPC 07350002010204

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

What happened

RaySearch Laboratories AB has recalled RayStation/RayPlan version 8B Service Pack 1 (Build Number 8.1.1.8), a stand-alone software treatment planning system. The recall affects one system distributed to Tennessee. The software contains a defect where applying pitch or roll correction can cause incorrect propagation of tabletop positions, resulting in erroneous lateral, longitudinal, and vertical values being calculated even though the pitch and roll correction itself is not propagated.

The recall notice does not specify a remedy 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 07350002010204

Source

Official record: FDA (Device enforcement) ↗

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

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