RAYSEARCH LABORATORIES AB: Medical Device Recall in 2014 - (Recall #: Z-1481-2014)

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:

RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.

Product Classification:

Class II

Date Initiated: February 14, 2014

Date Posted: April 30, 2014

Recall Number: Z-1481-2014

Event ID: 67535

Reason for Recall:

RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.

Status: Terminated

Product Quantity: 251 units (148 units domestically & 103 units internationally)

Code Information:

Versions: 2.0.0.15, 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 - USA Nationwide in the states of: AZ, CA, CT, CO, DE, FL, IL, NJ, NY, MA, MD, MS, OH, PA, TN, VA and WA. and the countries of Australia, New Zealand, Belgium, New South Wales, Republic of Korea, Italy, Germany, China, France, Switzerland, Netherlands, Spain, Austria, United Kingdom and Norway.

Voluntary or Mandated:

Voluntary: Firm initiated