RAYSEARCH LABORATORIES AB: Medical Device Recall in 2015 - (Recall #: Z-2457-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.

Product Classification:

Class II

Date Initiated: May 27, 2015

Date Posted: September 2, 2015

Recall Number: Z-2457-2015

Event ID: 71414

Reason for Recall:

Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.

Status: Terminated

Product Quantity: 126 programs

Code Information:

software build numbers are 4.7.1.10

Distribution Pattern:

Distributed in CO, IL, MI, NC, OH,TN, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated