Recall Z-1869-2014 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ever radiotherapy and/or chemotherapy are prescribed.
| Date | Jun 25, 2014 (initiated May 29, 2014) |
| Status | Terminated |
| Reason | MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order. |
| Root cause | Software design |
| Action | Elekta issued an Important Safety Notice dated May 29, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Corrective action that shall be taken: Notify the affected customers of the issue - To be completed 06/22/2014 Follow up with the affected customers for: Confirmation receipt of the LIN, AND Confirmation of installation of patch for the fix- To be completed 11/30/2014 The notice includes a confirmation which is to be returned. For further questions call (770) 670-2422. |
| Quantity | 101 |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TX, VT, VA and WA,. and the countries of Australia, Canada, New Zealand and United K |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123230 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc., Dec 12, 2012 |