Recall Z-0342-2012 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Elekta Synergy XVI X-ray Volume Imaging System To be used as part of radiation therapy treatment process.
| Date | Dec 1, 2011 (initiated Oct 20, 2011) |
| Status | Terminated |
| Reason | A small number of sites have experienced situations with kV generator transformers overheating due to a diode failure on the interface board. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Elekta, issued a "FIELD CHANGE ORDER MANDATORY ACTION" notice dated October 20, 2011 to its customers to add fuse protection for the kV transformers. The notice describes the product, problem, provides instructions and procedures and actions to be taken. The customers were instructed to follow any instructions or recommendations covered in the notice and to file the document in the Important Notice section of the appropriate User Manual. Elekta will contact the customer if the FCO is applicable to their kV generator. If you have any questions, call 770-300-9725. |
| Quantity | 123 |
| Distribution | Nationwide distribution: USA including states of: AL, AK, AZ, CA, CT, FL, GA, IL, IA, KY, MD, MS, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TX, VT, VA, WA, WV, WI, Puerto Rico, & DC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100115 | XVI R4.5 Elekta , Ltd., Mar 10, 2010 |