Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
This recall has been terminated (originally issued November 29, 2011).
- Company
- Elekta, Inc.
- Recall Initiated
- March 9, 2011
- Posted
- November 29, 2011
- Terminated
- August 9, 2012
- Recall Number
- Z-0305-2012
- Quantity
- 56
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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
Lot / Code Info
152019, 152448, 151076, 151954, 152454, 152117, 152452, 152393, 152394, 151942, 152163, 151955, 152176, 152222, 151931, 152388, 151141, 152365, 152303, 152358, 152353, 152359, 152352, 152362, 152305, 152468, 152481, 152469, 151812, 152432, 151260, 151952, 152370, 151396, 152301, 152248, 152425, 151155, 151156, 151157, 151412, 105984, 152307, 152308. 151443, 151545, 151628, 152207, 152271, 152373, 152371, 151080, 152211, 152158, 152392, 152331
Root Cause
Software design
Action Taken
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.