RAYSEARCH LABORATORIES AB: Medical Device Recall in 2018 - (Recall #: Z-0380-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

RayStation Product Usage: 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: July 17, 2017

Date Posted: January 24, 2018

Recall Number: Z-0380-2018

Event ID: 78900

Reason for Recall:

For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.

Status: Terminated

Product Quantity: 117 units

Code Information:

6.0.0.24 , 6.1.0.26 , 6.1.1.2 or 6.2.0.7

Distribution Pattern:

US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.

Voluntary or Mandated:

Voluntary: Firm initiated