Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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.

U.S. FDA — Device Enforcement · United States · 2015-05-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1954-2015
Date of alert
2015-05-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Viewray Incorporated
Product category
device
Product type
Devices
Reported risk: The software was failing to determine new patient locations if imaging is not enabled during treatment.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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