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

ViewRay MRIdian Linac System: Model No — recall Z-0482-2021

U.S. FDA — Device Enforcement · United States · 2020-10-20 · Class II

As described by U.S. FDA — Device Enforcement: ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic r

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0482-2021
Date of alert
2020-10-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Viewray, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution: US (nationwide) to states of: CA, NY, FL, IL, MI, MO, OR, WI and OUS countries of: France, Germany, Italy, United Kingdom, Taiwan, Netherlands, Israel, and Denmark.
Reported risk: There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.