RAYSEARCH LABORATORIES AB: Medical Device Recall in 2016 - (Recall #: Z-2206-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions.

Product Classification:

Class II

Date Initiated: July 1, 2016

Date Posted: July 27, 2016

Recall Number: Z-2206-2016

Event ID: 74618

Reason for Recall:

An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. -- To the best of the firm's knowledge, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect plan evaluation during treatment planning.

Status: Terminated

Product Quantity: US: 170 units

Code Information:

Software build numbers: 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.42, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11 and 5.0.2.35

Distribution Pattern:

California, Connecticut, Delaware, Florida, Hawaii, Maine, Missouri, New York, Ohio, Texas and Washington

Voluntary or Mandated:

Voluntary: Firm initiated