Reported Jul 8, 2015 · Terminated
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and…
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?
- Treatment Planning and Delivery System Software version 3.6. ViewRay. 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 Number
10000Serial #'s: 100101and 102
- Catalog/Part Number
- Amount recalled
- 3
Where it was sold
Why it was recalled
The software was failing to determine new patient locations if imaging is not enabled during treatment.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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