Recall Z-0724-2018 ยท IYE Accelerator, Linear, Medical
Elekta Limited
Integrity R1.2
| Date | Nov 20, 2017 |
| Status | Terminated |
| Reason | Potential for positional errors following automatic table movement (ATM). |
| Root cause | Software Design Change |
| Action | Customers were notified via letter on about [DATE]. Instructions include to post the notice in a place accessible to all users until the action is closed and to advise appropriate personnel working with the affected product of the recall action. Additionally Elekta plans to release Integrity R4.0.0, which should identify positional errors over 5 mm, in the first half of 2018. |
| Quantity | 539 units total |
| Distribution | Distributed domestically to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to ALBANIA, ALGERIA, ANTIGUA AND BARBUDA, ARGENTI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112613 | INTEGRITY(TM) Elekta Limited, Dec 16, 2011 |