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Recall Observatory FDA recall evidence

Device product

MRIdian Linac Radiation Therapy System Model 10000 and 20000

Z-0676-2020

March 03, 2019

Class II

Product summary

Firm
Viewray, Inc.
Event
Event 84303
Status
Terminated
Classification
Class II
Quantity
24 Systems
Official record key
device-enforcement:Z-0676-2020

Official wording

Reason: 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.

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

Distribution pattern: US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.