Recall Z-2002-2012 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Focal SIM Planning of radiation therapy
| Date | Jul 12, 2012 (initiated Jun 21, 2012) |
| Status | Terminated |
| Reason | Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports. |
| Root cause | Software design |
| Action | IMPAC Medical Systems, Inc. sent an Important Safety Notice LINFFM0001/1.0 on June 21, 2012, to consignees on concerning a patch to the software. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the DICOM coordinates option for Reports when printing the Setup Reference Diaglog. Customers were instructed go to www.elekta.com, select the SupportPlus Login at the tope of the page, enter their portal, select Downloads/Updates to download the latest patches. For questions regarding this recall call 770-670-2548. |
| Quantity | 38 units |
| Distribution | Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013112 | FOCAL SIM Computerized Medical Systems, Inc., Dec 5, 2001 |