MRIdian Linac Radiation Therapy System recall: Software Issue
MRIdian Linac Radiation Therapy System Model 10000 and 20000
Why was MRIdian Linac Radiation Therapy System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- MRIdian Linac Radiation Therapy System Model 10000 and 20000
- Recalling firm
- Viewray, Inc.
- Quantity
- 24 Systems
- Distribution
- US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE
- Recall date
- December 18, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)