RAYSEARCH LABORATORIES AB: Medical Device Recall in 2014 - (Recall #: Z-1307-2014)

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 Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.

Product Classification:

Class II

Date Initiated: February 6, 2014

Date Posted: April 9, 2014

Recall Number: Z-1307-2014

Event ID: 67504

Reason for Recall:

Potential for dose errors due to software program errors.

Status: Terminated

Product Quantity: 151 units Total (88 units domestically & 63 units internationally)

Code Information:

MODEL #(s): 2.5, 3.0, 3.5 and 4.0; VERSIONS: 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9

Distribution Pattern:

Worldwide Distribution - US including the states of NY, OH, MD, CT, CO, TN, IL, AZ, MS, NJ, PA, DE, FL, CA and WA., and the countries of New Zealand, Australia, Republic of Korea, China, Italy, Germany, Norway, Belgium, Switzerland, United Kingdom and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated