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Terminated

Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

FDA Recall Z-1954-2015 · Posted 2015-07-02

Recalling FirmViewray Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2015-05-07
Date Terminated2016-02-04
Product Quantity3

Reason for Recall

The software was failing to determine new patient locations if imaging is not enabled during treatment.

Firm Action

On May 7, 2015 the firm sent Customer Advisory Notification Letters to their customers.

Root Cause

Software design

Distribution Pattern

Distributed in the states of CA, MO & WI.

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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