ViewRay System, Radiation Therapy System
FDA Recall Z-1580-2015 · Posted 2015-05-05
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Recalling FirmViewray Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2015-01-15
Date Terminated2015-09-23
Product Quantity1
Reason for Recall
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.
Firm Action
On January 15, 2014, ViewRay personnel discussed the investigation of the issue (slice mismatch error) with the customer. The firm advised the customer that until the issue was corrected, to not treat patients in non HFS orientations, or to use the MR acquired from the ViewRay system as the primary plan series for non HFS scans. ViewRay installed software version 3.4.5.28 on January 20 and 21, 2014, in order to prevent this slice mismatch error from occurring in any patient position.
Root Cause
Software Design Change
Distribution Pattern
US distribution to MO.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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