RAYSEARCH LABORATORIES AB: Medical Device Recall in 2015 - (Recall #: Z-2785-2015)

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:

Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.

Product Classification:

Class II

Date Initiated: May 29, 2015

Date Posted: September 23, 2015

Recall Number: Z-2785-2015

Event ID: 71477

Reason for Recall:

An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images

Status: Terminated

Product Quantity: 20 devices

Code Information:

software build numbers are 4.7.0.15 or 4.7.1.10

Distribution Pattern:

Worldwide Distribution: US (nationwide) to state of WA; and countries of: France, Sweden, Austria, Spain, Germany, Italy, UK, New Zealand.

Voluntary or Mandated:

Voluntary: Firm initiated