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Terminated

Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy.

FDA Recall Z-1957-2011 · Posted 2011-04-12

Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-02-07
Date Terminated2011-12-23
Product Quantity421

Reason for Recall

An issue with the Varis Vision software where treatment can occur without the dynamic Multileaf Collimator component and may deliver a higher than expected dose of radiation.

Firm Action

Varian Medical Systems Urgent Medical Device Correction letters were sent to all affected customers on February 7, 2011.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001643VARIS 1.4GVarian Medical Systems, Inc. · 2000-06-23

Official Source

View FDA Recall →

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

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