RAYSEARCH LABORATORIES AB: Medical Device Recall in 2014 - (Recall #: Z-1806-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.

Product Classification:

Class II

Date Initiated: April 25, 2014

Date Posted: June 25, 2014

Recall Number: Z-1806-2014

Event ID: 68162

Reason for Recall:

This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.

Status: Terminated

Product Quantity: 25 sites/245 units (US), 25 sites/124 units (foreign)

Code Information:

Software version 4.0.3.4

Distribution Pattern:

Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy, New Zealand, Republic of Korea, Switzerland, Spain, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated