Recall Z-1146-2007 ยท IYE Accelerator, Linear, Medical
Northwest Medical Physics Equipment Inc
ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment.
| Date | Aug 8, 2007 (initiated Apr 7, 2006) |
| Status | Terminated |
| Reason | This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry angles; wrong shifts for two of three axes of treatment table movement. |
| Root cause | Software design |
| Action | Software to fix the problems was written and software users were notified of the availability by e-mail on 04/07/2006. They could download the fixed software from the firm's internet website. |
| Quantity | 141 copies |
| Distribution | Customers in USA, Korea, Spain and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904908 | STEREOTACTIC IRRADIATION SYSTEM Northwest Medical Physics Center, Jun 6, 1991 |