FDA-Device2020-04-01Class II
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 administer treatments. The system functionality can be configured based on user needs.
RAYSEARCH LABORATORIES AB
Hazard
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.
Sold states
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.
Affected count
1389 licenses
Manufactured in
Sveavagen 9, N/A, Stockholm, N/A, Sweden
Products
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 administer treatments. The system functionality can be configured based on user needs.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1598-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief