Recall Z-2840-2018 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD
| Date | Dec 1, 2017 |
| Status | Terminated |
| Reason | There is a potential for an uncontrolled extension of iViewGT / XVI detector arms. |
| Root cause | Component design/selection |
| Action | On December 6, 2017 Elekta sent notification to their customers informing them the following: Description of Problem: Elekta has identified that if the microswitch within the middle arm is not set up correctly, it is possible for the MV or kV detector arm to extend due to gravity. When the detector arm is fully open there is no risk. Details: In order for an uncontrolled extension to occur on a detector arm, the following conditions must be present: The microswitch (within the Solenoid Limit Switch of the PCB assembly in the middle arm) is activated incorrectly. The detector-locked solenoid |
| Quantity | 2,998 |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Alaska, District of Columbia, Hawaii and Puerto Rico A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051932 | ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 Elekta, Inc., Aug 12, 2005 |