Elekta, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1059-2014)

Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept the registration and the Table Move Assistant dialog box appears. (3) The Relative Actual column of the Table Move Assistant dialog box incorrectly appears blank. (4) When this occurs, XVI does not read the Absolute Actual position of the treatment table. This causes XVI to calculate the treatment table moves from the zero position of the treatment table (+0.0, + 0.0, + 0.0). (5) In XVI R5.0, if the Relative Set values are less than or equal to + or -2.5cm (for earlier releases of XVI, the value is + or -2cm), you can do remote automatic table movement (RATM) from the function keypad (FKP). (6) When you press the Table ASU (automatic setup) buttons, the treatment table moves to a position that was incorrectly calculated from XVI.

Class II

XVI can incorrectly calculate the target position of the treatment table.

Model 4.5, 4.5.1, 4.6, 5.0

Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL, AK, AZ, AR, CA, CT, FL, GA, ID, IL, KY, LA, MD, MA, MI, MN, MO, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, WY and DC., and the countries of Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Venezuela

Voluntary: Firm initiated