RAYSEARCH LABORATORIES AB: Medical Device Recall in 2014 - (Recall #: Z-1308-2014)

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

Product Classification:

Class II

Date Initiated: February 6, 2014

Date Posted: April 9, 2014

Recall Number: Z-1308-2014

Event ID: 67511

Reason for Recall:

RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.

Status: Terminated

Product Quantity: 19 units (16 units domestically & 3 units internationally)

Code Information:

Model#: 4.30; Version: 4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses

Distribution Pattern:

OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,

Voluntary or Mandated:

Voluntary: Firm initiated