Recall Z-1612-2008 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems Oncology Systems
Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48
| Date | Sep 23, 2008 (initiated Feb 13, 2008) |
| Status | Terminated |
| Reason | A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan. |
| Root cause | Software design |
| Quantity | 90 units |
| Distribution | Product was distributed throughout the USA (in LA, IN, GA, MD, IL, AR, CA, MA, FL, AZ, SC, MO, CO, AL, OK, WA, MI, IN, NY, TX, MS, NE, TN, VA, WI, OR, DC, and NC) and internationally (Japan, Columbia, Canada, India, Czech Republic, Turkey, Germany, Portugal, Venezuela, Australia, South Korea). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071873 | MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc., Aug 9, 2007 |