RAYSEARCH LABORATORIES AB recalls RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment p…

Recall date

February 10, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1712-2016

FDA classification

Class II

Brand / firm

RAYSEARCH LABORATORIES AB

Sold / distributed

**Domestic** AR, AZ, CA, CT, CO, DE, FL, GA, IL, LA, MI, MD, MS, MA, NY, NV, NJ, OH, OR, PA, NC, RI, TN, WA & Washington D.C; **Internationally** Algeria, Australia, Austria, Belgium, Canada, China, France, French Polynesia, Germany, Iran, Italy, Japan, Netherlands, New Zealand, Norway, Republic of…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.