MRIdian Linac Radiation Therapy System Model 10000 and 20000
Reported: December 18, 2019 Initiated: March 3, 2019 #Z-0676-2020
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.
Details
- Recalling Firm
- Viewray, Inc.
- Units Affected
- 24 Systems
- Distribution
- US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE
- Location
- Mountain View, CA
Frequently Asked Questions
What product was recalled? ▼
MRIdian Linac Radiation Therapy System Model 10000 and 20000. Recalled by Viewray, Inc.. Units affected: 24 Systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0676-2020.
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