VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer
FDA device recall Z-1385-2012 · posted 2012-04-10 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- 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.
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- KXK
- Quantity affected
- 1377 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2012-01-25
- Date posted
- 2012-04-10
- Date terminated
- 2012-11-07
- Location
- Charlottesville, VA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARISEED 7.1 (K030534) | Varian Medical Systems | 2003-05-21 |