Z-1803-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- November 18, 2019
- Termination Date
- February 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32
Product Description
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
Reason for Recall
Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.
Distribution Pattern
Worldwide distribution. US states of MO, WI, CA, FL, MI, NY, MI, IL, and MA. South Korea, Netherlands, Italy, Japan, Germany, UAE, Turkey, France, Israel, Denmark, Switzerland, and United Kingdom. The distributors are assigned to applicable regions. Firm send the Urgent Device Corrections to them and they forwarded them to the sites.
Code Information
Model No.10000 - Serial No's:. 100,104,105,112,113 Model No. 20000 - Serial No's: 101,102,107,108,200,201,203,204,206,207,209,211, 213,214,215,216,217,218,221,223,225,227,228,232,238,240,243, 244,247,250