Recall Z-1020-04 ยท MUJ System, Planning, Radiation Therapy Treatment
Radionics, Inc.
Radionics Head and Neck Localilizer (HNL), Version B
| Date | Jul 20, 2004 (initiated May 25, 2004) |
| Status | Terminated |
| Reason | Software may provide inaccurate coordinates and cause mistreatment |
| Root cause | Other |
| Action | Radionics notified users by telephone and follow-up letters dated 5/25/04 via facsmile. Users are requested not to use the system. A corrected software will be issued. |
| Quantity | 4 |
| Distribution | Canada, Germany, Greece |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991237 | XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL Radionics, Inc., Aug 30, 1999 |