FDA recall Z-0380-2018

RAYSEARCH LABORATORIES AB · Class II · device

Product

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.

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2017-07-17
Report date
2018-01-24
Termination date
2018-08-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0380-2018