Recall Z-1065-2014 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
| Date | Mar 7, 2014 (initiated May 28, 2013) |
| Status | Terminated |
| Reason | Customers are resetting the default values outside recommended factory settings. |
| Root cause | Device Design |
| Action | Elekta sent an Important Field Safety Notice dated May 2013 to all affected customers. The Notice identified the affected product, problem, clinical impact and actions to be taken. Customers were instructed to adhere to the instructions and advice given in manuals and system dialogues. For question contact your local Elekta office. |
| Quantity | 472 units |
| Distribution | USA Nationwide Distribution in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC and including Puerto Rico. |
| 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 |