PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: March 18, 2020 Initiated: February 20, 2020 #Z-1468-2020

Product Description

RayStation/RayPlan 9B, Build Number 9.1.0.933, 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.

Details

Recalling Firm
RAYSEARCH LABORATORIES AB
Units Affected
1 system in the U.S.
Distribution
The products were distributed to the following US states: TN
Location
Stockholm

Frequently Asked Questions

What product was recalled?
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 1 system in the U.S..
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 18, 2020. Severity: Moderate. Recall number: Z-1468-2020.