RayStation 의 리콜

Recall

75173

Class 2

Z-0038-2017

2016-09-01

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149543

Raysearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. the correction concerns two issues found with the dose calculation when using a region of interest (roi) of type fixation or support with material override within the patient outline (external roi) in raystation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (inversearc 1.0).

RaySearch sent a Field Safety Notice, on September 1, 2016, (RSL-D-61-301, dated 9/5/2016), was sent by e-mail to all affected customers. ACTIONS TO BE TAKEN BY THE USER Do not use ROIs of type Fixation or Support within the patient outline. Always use other ROI types for material override within the External ROI. A small overlap with the External ROI is acceptable if the Fixation or Support ROI is mainly outside the External ROI. Please educate planning staff and all users about this workaround. Inspect your product and identify all installed units with the above software version number, then confirm you have read and understood this notice (contact information below). SOLUTION A correction of these issues will be available in the next version of RayStation, scheduled for market release in December 2016. In the meantime, this field safety notice is distributed to all customers. Until a corrected version has been installed, all affected users must maintain awareness of this field safety notice. TRANSMISSION OF THIS FIELD SAFETY NOTICE This notice needs to be passed on to all those who need to be aware within your organization. Please maintain awareness of this notice as long as this version of RayStation is in use to ensure effectiveness of the workaround.