Recall Z-0931-2013 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
| Date | Mar 10, 2013 (initiated Dec 19, 2012) |
| Status | Terminated |
| Reason | The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name. |
| Root cause | Software design |
| Action | Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated December 2012 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The IFSN informs the user in the TPS, to give the different volumes different structure names. After importing the patient data set from the TPS, make sure that the structure contours are correct. Users are requested to return the signed acknowledgement. Contact your local Elekta office for questions regarding this notice. |
| Quantity | 164 |
| Distribution | Nationwide Distribution-DC, Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051932 | ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 Elekta, Inc., Aug 12, 2005 |