Reported Oct 21, 2015 · Terminated
MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision…
Viewray Incorporated
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 Incorporated · 2 Thermo Fisher Way · Oakwood Village, OH · 44146-6536
Is this the product you have?
- MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
- Lot codes and dates
- Catalog/Part Number10000
- Serial Numbers
100101102& 105
- Amount recalled
- 4 units
Where it was sold
Why it was recalled
ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.
This product could cause temporary or reversible health problems — stop using it.
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