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Terminated

EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical Systems, Inc, Palo Alto, CA 94304.

FDA Recall Z-0582-04 · Posted 2004-07-20

Recalling FirmVarian Medical Systems
Recall StatusTerminated
Product CodeJAQ
Date Initiated2004-02-06
Date Terminated2004-09-21
Product Quantity203

Reason for Recall

Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy.

Firm Action

The recalling firm notified end users by letters flagged 'Urgent Medical Device Correction' on 2/2/04. The notification reminds users to verify the decay factor before patient treatment. The letter also advises that instrument software be be updated commencing March 2004.

Root Cause

Other

Distribution Pattern

Product was distributed to end users in the United States and internationally.

Official Source

View FDA Recall →

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

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