Recall Z-1059-2014 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
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 Assistan
| Date | Feb 20, 2014 (initiated Nov 25, 2013) |
| Status | Terminated |
| Reason | XVI can incorrectly calculate the target position of the treatment table. |
| Root cause | Software design |
| Action | Elekta sent an Important Field Safety Notice dated November 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Potential collision risk when using XVI and external beam shaping devices released November 25, 2013 (Only software versions R4.5, R4.5.1, R4.6 and R5.0 are applicable to this recall). (All software versions R4.6 in this notices are applicable to this recall). Recommendations to Users - Monitor the Actual column of the Table Move Assistant dialog box. If the Actual is blank, do not press the ASU b |
| Quantity | 1028 |
| Distribution | 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, B |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100115 | XVI R4.5 Elekta , Ltd., Mar 10, 2010 |