Recall Z-1598-2020 · MUJ System, Planning, Radiation Therapy Treatment

RAYSEARCH LABORATORIES AB

RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to admin

Date	Mar 4, 2020
Status	Open, Classified
Reason	Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.
Root cause	Under Investigation by firm
Action	Field Safety Notice, Medical Device Correction #56089 was emailed to customers on 3/4/20. ACTIONS TO BE TAKEN BY THE USER " Do not use Siemens Virtual Wedge fields outside the Siemens recommended specification. If a field outside the recommended specification with a virtual wedge is sent to the LINAC, the treatment machine console (console software versions 8 and higher) will display a warning message, for example Initial gap > 1 cm! Proceed (y/n)?, or The distance between the static jaw and the moving jaw is greater than 1 cm. Do you want to continue? (y/n). If this happens, select n to pr
Quantity	1389 licenses
Distribution	US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K190387

RayStation
RaySearch Laboratories AB (PUBL), Jun 19, 2019