Z-1815-2017 Class II Terminated
FDA device recall Z-1815-2017 was initiated by RAYSEARCH LABORATORIES AB on January 18, 2017 and is designated Class II. Reason for recall: An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citr… The recall status is terminated (terminated June 12, 2019). Affected quantity: 741 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- January 18, 2017
- Termination Date
- June 12, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 741 units
Product Description
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation 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. The system functionality can be configured based on user needs
Reason for Recall
An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citrix graphics board (graphics card) an erroneous calculation may be allowed.
Distribution Pattern
Nationwide Distribution to AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, LA, MN, MD, MA, MI, MS, MT, NJ, NY, NC, NV, OH, OK, OR, PA, RI, TN, TX, VA, VT, VI, WA, WI, and Washington D.C.
Code Information
4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11, 5.0.2.35