Recall Z-0305-2012 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
| Date | Nov 29, 2011 (initiated Mar 9, 2011) |
| Status | Terminated |
| Reason | If "Confirm" or "Unconfirm" settings are clicked during the "Terminated Checking" phase of treatment delivery, Desktop Pro cancels the loaded beam and sets the Beam MUs to zero. Desktop Pro then sends the delivered MUs to MOSAIQ a a zero value. |
| Root cause | Software design |
| Action | Elekta sent an IMPORTANT NOTICE letter dated March 9, 2011 to affected customers. The notice identified the product, the problem, and the corrective action to be taken by the customer. The notice advise all customers to follow any instructions or recommendations covered in the Notice. For questions call +44(0)1293 654200. |
| Quantity | 56 |
| Distribution | Nationwide Distribution (USA) including the states of: AZ, CA, GA, IL, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, TN, VA, WI and Puerto Rico |
| 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 |