RAYSEARCH LABORATORIES AB: Medical Device Recall in 2018 - (Recall #: Z-0294-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.

Product Classification:

Class II

Date Initiated: September 21, 2018

Date Posted: November 7, 2018

Recall Number: Z-0294-2019

Event ID: 81269

Reason for Recall:

Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.

Status: Terminated

Product Quantity: 110 units

Code Information:

Software, include version number: 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10, 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 5.0.0.37 , 5.0.1.11 , 5.0.2.3 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 7.0.0.19

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated