FDAJanuary 15, 2015device
ViewRay System, Radiation Therapy System
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.
What to do
FDA enforcement status: Terminated
Brands named
viewray
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiat...2021-05-04
- FDAViewRay MRIdian System: Model No. 10000, 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 radiosur...2020-10-20
- FDAViewRay 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 ra...2020-10-20
- FDAViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software2019-11-18
- FDAMRIdian Linac Radiation Therapy System, Model 20000.2019-03-18
- FDAMRIdian Linac Radiation Therapy System Model 10000 and 200002019-03-03
- FDAMRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated2016-03-07
- FDAMRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.2015-12-24
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