Device Recall RayStationTherapy Treatment Planning System 의 리콜

Recall

73575

Class 2

Z-1712-2016

2016-02-10

2016-05-25

Terminated

United States

2017-04-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144491

A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. the views can become unsynchronized with the stored data if simultaneously right clicking, pressing ctrl-s or ctrl-z while the left mouse button is held down. this bug does not affect dose computations, which are based on the stored system state.

On February 10, 2016, RaySearch Laboratories distributed Field Safety, Medical Device Correction notices and Reply Forms to their customers via email. To determine if the software version you are using is affected, open the About RayStation dialog in the RayStation application and check if the build number reported. This bug does not affect dose computations. Dose is always computed based on the stored system state. Actions to be taken by the user include the following: Always release the left mouse button before using other keys or mouse buttons, If the warning message "Temporary items should not be visible on approval" is displayed or if there is some suspicion that the bug may have triggered in structure definition, either review the structures in the Plan approval dialog, or close and reload the patient case and review the structures again. All customers should educate planning staff and all users about this workaround. All customers are advised to inspect product and identify all installed units with the referenced software version number, then confirm that you have read and understood the notice by completing and returning the reply form. The completed reply form should be returned to Freddie Cardel, freddie.cardel@raysearchlabs.com, fax 888-501-7195. Customers with questions can call 1-877-778-3849, available east coast business hours all US working days.