RAYSEARCH LABORATORIES AB: Medical Device Recall in 2013 - (Recall #: Z-1419-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.

Product Classification:

Class II

Date Initiated: February 15, 2013

Date Posted: June 5, 2013

Recall Number: Z-1419-2013

Event ID: 65136

Reason for Recall:

Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.

Status: Terminated

Product Quantity: Domestic: 70 units; Foreign: 27 units

Code Information:

Software version and build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251 (to determine if the version used is affected, bring up the About box in the RayStation application and check the build number reported0.

Distribution Pattern:

Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated