|
Class 2 Device Recall MOSAIQ |
|
Date Initiated by Firm |
May 29, 2014 |
Date Posted |
June 25, 2014 |
Recall Status1 |
Terminated 3 on July 16, 2021 |
Recall Number |
Z-1869-2014 |
Recall Event ID |
68386 |
510(K)Number |
K123230
|
Product Classification |
Accelerator, linear, medical - Product Code IYE
|
Product |
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. |
Code Information |
Released builds 2.50.04D5 and higher |
Recalling Firm/ Manufacturer |
Elekta, Inc. 400 Perimeter Center Ter Ne Ste 50 Atlanta GA 30346-1227
|
For Additional Information Contact |
Linda Wetsel 770-670-2422
|
Manufacturer Reason for Recall |
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.
|
FDA Determined Cause 2 |
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 in Commerce |
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 Kingdom. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.
|
|
|
|