Recall Z-0720-2017 · MUJ System, Planning, Radiation Therapy Treatment

RAYSEARCH LABORATORIES AB

Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.

Date	Oct 11, 2016
Status	Terminated
Reason	An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Reference as the displayed auxiliary CT set exists in another case, the dose display may be incorrect. When the error occurs, the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. The dose value normally displayed in the upper left corner when pointing in the 2D view may be incorrect or missing.
Root cause	Software design
Action	On October 11, 2016 RaySearch Laboratories distributed a Field Safety Notice, Medical Device Correction #13529 to customers via email. Customers were instructed to take caution when a patient has multiple cases. The following may be incorrect if there are image sets that shre the same Frame of Reference residing in different cases: Display of evaluation dose computed on another CT image set and Dose tracking fraction dose and deformed dose. Until a corrected version has been installed, all affected users must maintain awareness of this field safety notice. In these cases, the display of
Quantity	540 units
Distribution	US Nationwide Distribution in the states of AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, MA, MD, MN, MI, MS, MO, NJ, NY, NC, OH, PA, RI, TX & WA
FDA record	Open on fda.gov

510(k) clearances named in this recall

K160093

RayStation
RaySearch Laboratories AB (PUBL), Apr 8, 2016