Recall Z-1152-2007 ยท IYE Accelerator, Linear, Medical
Northwest Medical Physics Equipment Inc
ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software.
| Date | Aug 8, 2007 (initiated Apr 28, 2005) |
| Status | Terminated |
| Reason | When ISOLOC version 6.0 and 4.2 distance unit is set to centimeter, the localization coordinates were rounded to the nearest millimeter which could affect positioning by 0.5 mm. |
| Root cause | Software design |
| Action | Software to fix the described problems was written and customers contacted by e-mail on 04/28/2005, that a software patch, titled 04282005, was available on the firm's internet website. |
| Quantity | 84 |
| Distribution | Worldwide, including 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 |