Recall Z-1244-2015 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Focal Sim radiation therapy treatment planning system
| Date | Mar 4, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| Reason | Incorrect CT to ED when using the Monaco Image Statistics Tool. |
| Root cause | Software design |
| Action | An Important User Notice (IUN 382-03-FCL-001) was issued to customers on 12/19/2014. The notice included a workaround to be used until a new software release. The notice also included an acknowledgement form to be returned. |
| Quantity | 907 |
| Distribution | Worldwide distribution. US nationwide (AL, AK, CA, CO, CT, FL, IL, IN, LA, MD, MA, MI, MO, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WY, DC), Puerto Rico, Argentina, Austria, Australia, Bulgaria, Bahrain, Brazil, Belarus, Canada, Chile, China, Colombia, Cuba, Cyprus, Czech Republic, Germa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013112 | FOCAL SIM Computerized Medical Systems, Inc., Dec 5, 2001 |