RAYSEARCH LABORATORIES AB: Medical Device Recall in 2013 - (Recall #: Z-0281-2014)

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:

Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0

Product Classification:

Class II

Date Initiated: October 23, 2013

Date Posted: November 20, 2013

Recall Number: Z-0281-2014

Event ID: 66600

Reason for Recall:

Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.

Status: Terminated

Product Quantity: 195 units domestically

Code Information:

Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.

Distribution Pattern:

US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.

Voluntary or Mandated:

Voluntary: Firm initiated