Elekta Synergy XVI 4.5 and R4.6 To be used as part of radiation therapy treatment process.
This recall has been terminated (originally issued February 21, 2012).
- Company
- Elekta, Inc.
- Recall Initiated
- January 26, 2012
- Posted
- February 21, 2012
- Terminated
- April 17, 2012
- Recall Number
- Z-1066-2012
- Quantity
- 96 units
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
If a user, using an on-line correction protocol, clicks the accept correction button, an approval dialog box appears. If cancel is selected, the table correction values return to their initial values, but the image panes continue to display the changed position.
Distribution
Nationwide Distribution including AR, AZ, CA, CT, FL, 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
Lot / Code Info
152433, 152019, 151176, 152248, 152262, 152454, 105941, 151802, 152427, 151628, 151362, 152207, 151545, 151566, 152271, 152425, 152452, 152491, 151808, 152163, 152331, 151443, 151955, 152585, 152522, 151514, 151791, 151430, 151931. 105984, 151412, 152388, 151616, 151141, 152303, 151892, 151785, 152358, 152223, 152305, 152468, 151260, 152469, 152481, 152601, 152356, 152175, 152365, 152177, 152257, 151952, 152353, 152359, 152362, 152352, 152371, 152370, 151942, 151820, 151770, 151864, 151396, 152448, 151954, 151076, 151309, 152103, 152301, 151634, 151793, 152210, 152211, 151080, 152373, 152222, 152158, 152392, 151684, 152530, 152536, 151168, 151839, 151156, 151155, 151157, 152117, 151710, 152308, 152307, 152504, 151683, 151764, 151885, 152432, 151812, 152549.
Root Cause
Software design
Action Taken
ELEKTA sent an Important Field Safety Notice (20001507042) dated January 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For questions regarding this recall call 770-670-2548