RAYSEARCH LABORATORIES AB: Medical Device Recall in 2019 - (Recall #: Z-1930-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy

Product Classification:

Class II

Date Initiated: November 20, 2017

Date Posted: July 10, 2019

Recall Number: Z-1930-2019

Event ID: 83152

Reason for Recall:

When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong

Status: Terminated

Product Quantity: 744

Code Information:

Software versions: 3.5.0.16 , 3.5.1.6 , 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 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 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35 , 5.0.3.17 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 and 6.2.0.7

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated