Reported Dec 18, 2019 · Terminated
MRIdian Linac Radiation Therapy System Model 10000 and 20000
Viewray, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Viewray, Inc. · 815 E Middlefield Rd · Mountain View, CA · 94043-4025
Is this the product you have?
- MRIdian Linac Radiation Therapy System Model 10000 and 20000
- Lot codes and dates
- Serial Numbers
100101102103104105107108112113201202203204205206209211213214217221223225
- Device Listing NumberD158423 and D297999
- Serial Numbers
- Amount recalled
- 24 Systems
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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