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Terminated

medical device and software systems

FDA Recall Z-1314-04 · Posted 2004-08-07

Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeMUJ
Date Initiated2004-06-24
Date Terminated2004-12-23
Product Quantity28 units

Reason for Recall

a malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a non-varian machine and a varian machine and a non-varian field is loaded in the treatment session.

Firm Action

Notification letter to consignees sent 06/14/2004.

Root Cause

Other

Distribution Pattern

produt was distributed to 28 medical facilities, 12 in the United states, 16 foreign

Official Source

View FDA Recall →

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

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