Reported Jun 16, 2021 · Terminated
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning…
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?
- ViewRay MRIdian Linac SystemModel No. 20000-01 software
- CE 0086 - Product Usageintended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system
- Lot codes and dates
- French version of the
- TDS software affected serial numbers214, 215, 226 and 240 German or Italian versions of the
- TDS software affected serial numbers
203232108 and 244
- Amount recalled
- 8 versions
Why it was recalled
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
This product could cause temporary or reversible health problems — stop using it.
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