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

Recall Z-0115-2016 — 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.

U.S. FDA — Device Enforcement · United States · 2015-08-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0115-2016
Date of alert
2015-08-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Viewray Incorporated
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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