PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 24, 2018 Initiated: July 17, 2017 #Z-0380-2018

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.

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.

Details

Recalling Firm
RAYSEARCH LABORATORIES AB
Units Affected
117 units
Distribution
US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.
Location
Stockholm, N/A

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 117 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2018. Severity: Moderate. Recall number: Z-0380-2018.

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