Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Recall Z-2085-2015 · Posted 2015-07-16
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Recalling FirmViewray Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2015-04-01
Date Terminated2016-02-04
Product Quantity3
Reason for Recall
ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
Firm Action
ViewRay sent a Customer Advisory Notification Letters dated April 1, 2015 to thier customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns regarding this issue, contact ViewRaylM Customer Support at [email protected] or call the ViewRaylM Customer Support center at 855-286-8875.
Root Cause
Software Design Change
Distribution Pattern
US Nationwide Distribution in the states of CA, MO & WI
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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