RAYSEARCH LABORATORIES AB: Medical Device Recall in 2012 - (Recall #: Z-2324-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

Product Classification:

Class II

Date Initiated: May 9, 2012

Date Posted: September 12, 2012

Recall Number: Z-2324-2012

Event ID: 62967

Reason for Recall:

The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. The dose calculation is not correctly normalized in the unusual case of preventing the optimizatio

Status: Terminated

Product Quantity: 19 units

Code Information:

Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years.

Distribution Pattern:

Worldwide distribution: USA (nationwide) including states of: FL, MA, NJ, and NY; and countries of: Canada Germany, Netherlands and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated