Z-0380-2018 Class II Terminated
FDA device recall Z-0380-2018 was initiated by RAYSEARCH LABORATORIES AB on July 17, 2017 and is designated Class II. 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… The recall status is terminated (terminated August 29, 2018). Affected quantity: 117 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2018
- Initiation Date
- July 17, 2017
- Termination Date
- August 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 117 units
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.
Distribution Pattern
US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.
Code Information
6.0.0.24 , 6.1.0.26 , 6.1.1.2 or 6.2.0.7