Z-0806-2016 Class II Terminated
FDA device recall Z-0806-2016 was initiated by Viewray Incorporated on December 24, 2015 and is designated Class II. Reason for recall: The system loaded a completion fraction in the incorrect order after a treatment interruption. The recall status is terminated (terminated February 22, 2017). Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 24, 2016
- Initiation Date
- December 24, 2015
- Termination Date
- February 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
Reason for Recall
The system loaded a completion fraction in the incorrect order after a treatment interruption.
Distribution Pattern
US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.
Code Information
Model #: 10000, Serial #'s: 100, 101, 102, 104 & 105