Z-0676-2020 Class II Terminated
FDA device recall Z-0676-2020 was initiated by Viewray, Inc. on March 3, 2019 and is designated Class II. Reason for recall: Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software op… The recall status is terminated (terminated April 28, 2021). Affected quantity: 24 Systems.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- March 3, 2019
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 Systems
Product Description
MRIdian Linac Radiation Therapy System Model 10000 and 20000
Reason for Recall
Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.
Distribution Pattern
US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE
Code Information
Serial Numbers: 100, 101, 102, 103, 104, 105, 107, 108, 112, 113, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225 Device Listing Number: D158423 and D297999