Recall Z-0320-2012 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Elekta Synergy XVI R.4.5 and R4.6 ProducT Usage: To be used as part of radiation therapy treatment process.
| Date | Dec 1, 2011 (initiated Oct 14, 2011) |
| Status | Terminated |
| Reason | The software did not operate as expected. |
| Root cause | Software design |
| Action | Elekta sent an IMPORTANT NOTICE letter dated October 14, 2011 to all affected consignees. The letter identified the affected product, the problem, and the actions to be taken. This notice contained precautionary measures that are required for the operation of the equipment. The notice advise all customers to follow any instructions or recommendations covered in the Notice. The notice instructs Users to file this document in the Important Notice section of the appropriate User Manual. For questions contact your local Elekta representative. |
| Quantity | 77 |
| Distribution | Nationwide Distribution (USA) - including the states of: AZ, CA, CT, GA, ID, IL, LA, MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OK, OR, PA, RI, TN, VA, WA, WI and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100115 | XVI R4.5 Elekta , Ltd., Mar 10, 2010 |