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Terminated

MRIdian Linac Radiation Therapy System, Model 20000.

FDA Recall Z-1251-2019 · Posted None

Recalling FirmViewray, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2019-03-18
Date Terminated2022-06-16
Product Quantity17 devices

Reason for Recall

A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.

Firm Action

An undated letter was issued via email to customers on 3/18/2019, except for one customer who was issued the letter on 3/26/2019.

Root Cause

Software design

Distribution Pattern

Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170751MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated · 2017-06-07

Official Source

View FDA Recall →

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

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