Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
This recall has been terminated (originally issued September 1, 2010).
- Company
- Elekta, Inc.
- Recall Initiated
- September 1, 2010
- Terminated
- December 14, 2010
- Recall Number
- Z-0350-2011
- Quantity
- 23 units
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
It is possible to do couch corrections twice if both Couch Move Assistant in MOSAIQ and Remote Automatic Table in XVI are configured when in SYNERGISTIQ mode.
Distribution
Nationwide distribution: AZ, CA, DC, IL, KY, MA, MI, MS, NV, NY, OH, OR, PA, VT, and WV.
Lot / Code Info
Serial Numbers 152019, 151866, 151259, 151522, 151969, 152192, 152126, 152115, 152116, 152176, 151931, 152177, 151523, 151626, 151842, 152158, 152079, 152080, 151250, 152064, 152207, 151628, and 151362
Root Cause
Other
Action Taken
Elekta sent an "Important Notice A340" dated September 1, 2010 to all customers. The notice described the product, problem and actions to be taken by the customer. The customers were instructed to make a decision if XVI or MOSAIQ does the corrective table movement; configure and ensure that the system only uses RATM or CMA for the corrective table movement, when in SYNERGISTIQ mode, and complete and return the IMPORTANT NOTICE Confirmation of Receipt form via fax at +44(0)1293 654401. If you have any questions contact your local service representative at +44(0)1293 654200.