FDA Recall Terminated

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.

Recall: Z-1869-2014 · Initiated May 29, 2014

Recall

Recall Number
Z-1869-2014
Event Number
68386
Firm
Elekta, Inc.
FEI Number
1037831
Product Code
IYE
Status
Terminated
Root Cause
Software design
Initiated
May 29, 2014
Posted
June 25, 2014
Terminated
July 16, 2021
Address
400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227

Description

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.

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.

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.

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.

Quantity

101