RAYSEARCH LABORATORIES AB: Medical Device Recall in 2016 - (Recall #: Z-0079-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Radiation Therapy Treatment Planning System, Model 5.0

Product Classification:

Class II

Date Initiated: May 30, 2016

Date Posted: October 19, 2016

Recall Number: Z-0079-2017

Event ID: 74750

Reason for Recall:

For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.

Status: Terminated

Product Quantity: 491 units (187 domestically & 304 internationally)

Code Information:

5.0.0.37, 5.0.1.11 and 5.0.2.35

Distribution Pattern:

AZ, CA, FL, MT, NC NY, TX, OH & WA

Voluntary or Mandated:

Voluntary: Firm initiated