Recall Z-1442-2008 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.
| Date | Aug 15, 2008 (initiated Jan 3, 2008) |
| Status | Terminated |
| Reason | If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment. |
| Root cause | Software design |
| Action | The firm has upgraded all user sites through normal course of service and installation activities. Notification letters were distributed starting January 03, 2008. |
| Quantity | 291 units |
| Distribution | Worldwide Distribution -- USA including states of GA, MI, NY, MN, TX, TN, CA, MD, KS, AL, KY, CT, WI, LA, NC, NJ, PA, IL, RI, FL, NE, AK, VA, WV, NV, MO, TN, OR, IN, MA, CT, AL, AZ, NH, ID, OH, SC, CO, CT, ND, WA, and UT, and countries of Sweden, Switzerland, Germany, Denmark, Japan, UK, France, Ita |
| FDA record | Open on fda.gov |