Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by Siemens Medical Solutions Oncology Care Systems, Concord, CA.
This recall has been terminated (originally issued January 29, 2009).
- Recall Initiated
- October 23, 2008
- Posted
- January 29, 2009
- Terminated
- December 9, 2010
- Recall Number
- Z-0927-2009
- Quantity
- 36 units
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
Reason for Recall
If a plan contains a sequence of beams, including at least 1 ARC treatment beam and if during the setup stage of a beam following an ARC beam in the delivery sequence a termination occurs, and the user selects the immediate resumption feature, syngo RT Therapist Express systems will display and record a second delivery of a prior beam and not the delivery of the current beam in certain circumstanc
Distribution
Worldwide Distribution including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium, New Zealand, France, Malaysia, Spain, and Canada.
Lot / Code Info
Part Number 8139789, Serial Numbers: 5190, 5350, 5355, 5364, 5367, 5374, 5377, 5398, 5405, 5410, 5419, 5424, 5165, 5166, 5202, 5238, 5298, 5306, 5342, 5352, 5365, 5366, 5373, 5378, 5379, 5380, 5397, 5399, 5400, 5401, 5402, 5409, 5414, 5416, 5423 and 5425.
Root Cause
Software design
Action Taken
An Urgent Medical Device Customer Safety Letter dated October 23, 2008 was issued to consignees via certified mail. The letter identified the issue and preventive measures for consignees. Monitoring will be done via return cards. Follow-up to be conducted via telephone.