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Terminated

VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures.

FDA Recall Z-1385-2012 · Posted 2012-04-10

Recalling FirmVarian Medical Systems, Inc.
Recall StatusTerminated
Product CodeKXK
Date Initiated2012-01-25
Date Terminated2012-11-07
Product Quantity1377 units

Reason for Recall

Brachytherapy device requires the user to enter radioactive source activity, but software may specify unintended units for activity and lead to overdose in patient treatment.

Firm Action

Varian Medical Systems notified direct account healthcare practitioners/ medical physicists with "Urgent Medical Device Correction/Urgent Field Safety Notice" letters by mail on 01/19/2012. Varian's advisory described how to mitigate user error and the firm's intentions to revise Instructions for Use. Technical Support phone numbers were provided for US and international customers.

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030534VARISEED 7.1Varian Medical Systems · 2003-05-21

Official Source

View FDA Recall →

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

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