RAYSEARCH LABORATORIES AB: Medical Device Recall in 2016 - (Recall #: Z-0720-2017)

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:

Radiation Therapy Treatment Planning System Product Usage: 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.

Product Classification:

Class II

Date Initiated: October 11, 2016

Date Posted: December 14, 2016

Recall Number: Z-0720-2017

Event ID: 75633

Reason for Recall:

An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Reference as the displayed auxiliary CT set exists in another case, the dose display may be incorrect. When the error occurs, the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. The dose value normally displayed in the upper left corner when pointing in the 2D view may be incorrect or missing.

Status: Terminated

Product Quantity: 540 units

Code Information:

Build No: "5.0.0.37, 5.0.1.11 or 5.0.2.35. Only 5.0.2.35 was distributed in the U.S.

Distribution Pattern:

US Nationwide Distribution in the states of AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, MA, MD, MN, MI, MS, MO, NJ, NY, NC, OH, PA, RI, TX & WA

Voluntary or Mandated:

Voluntary: Firm initiated