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.
This recall has been terminated (originally issued April 10, 2012).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- January 25, 2012
- Posted
- April 10, 2012
- Terminated
- November 7, 2012
- Recall Number
- Z-1385-2012
- Quantity
- 1377 units
- Firm Location
- Charlottesville, VA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution
Lot / Code Info
device is not coded
Root Cause
Labeling design
Action Taken
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.
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