Z-1309-2016 Class II Terminated
FDA device recall Z-1309-2016 was initiated by Viewray Incorporated on March 7, 2016 and is designated Class II. Reason for recall: When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the n… The recall status is terminated (terminated February 22, 2017). Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 6, 2016
- Initiation Date
- March 7, 2016
- Termination Date
- February 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated
Reason for Recall
When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.
Distribution Pattern
Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.
Code Information
Model number: 10000 Catalog/Part Number: 10000 Serial Numbers: 100, 101, 102, 104 & 105