Company: ViewRay Inc.
Date of Enforcement Report: 5/13/2015
Class lI:
PRODUCT
ViewRay System, Radiation Therapy System
Recall Number Z-1580-2015
REASON
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.
RECALLING FIRM/MANUFACTURER
ViewRay Inc, Oakwood Village, OH on 1/15/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
1
DISTRIBUTION
US distribution to MO..
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