Recall Z-0582-04 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems
EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical Systems, Inc, Palo Alto, CA 94304.
| Date | Jul 20, 2004 (initiated Feb 6, 2004) |
| Status | Terminated |
| Reason | Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy. |
| Root cause | Other |
| 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. |
| Quantity | 203 |
| Distribution | Product was distributed to end users in the United States and internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.