FDAFDA · Food and drugs·Recall number Z-1954-2015
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.
Published July 8, 2015 · Recall initiated: May 7, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The software was failing to determine new patient locations if imaging is not enabled during treatment.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Viewray Incorporated
- Distributor
- Distributed in the states of CA, MO & WI.
- Lot
- Catalog/Part Number: 10000; Serial #'s: 100, 101, and 102
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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