EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical
FDA device recall Z-0582-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems
- Reason for recall
- Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy.
- Action taken
- 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
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 203
- Distribution
- Product was distributed to end users in the United States and internationally.
- Date initiated
- 2004-02-06
- Date posted
- 2004-07-20
- Date terminated
- 2004-09-21
- Location
- Charlottesville, VA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.