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Terminated

MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.

FDA Recall Z-0806-2016 · Posted 2016-02-12

Recalling FirmViewray Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2015-12-24
Date Terminated2017-02-22
Product Quantity5 units

Reason for Recall

The system loaded a completion fraction in the incorrect order after a treatment interruption.

Firm Action

ViewRay sent an Customer Advisory Notice dated December 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Workaround: If you want to move a completion plan to a later date in the Delivery Calendar then do not schedule it until right before you are ready to treat that completion plan. While we will address this issue in the next release of software we recommend that in the event of a completion plan you always review the plan name loaded on the TPDS and verify the remaining time and beams are as expected with the completion plan. If you have any questions or concerns regarding this issue, please do not hesitate to contact ViewRay Customer Support at [email protected] or call the ViewRay" Customer Support center at 855-286- 8875.

Root Cause

Software design

Distribution Pattern

US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111862VIEWRAY SYSTEMViewray, Incorporated · 2012-05-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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