—#127501

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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123230
Affected lot / code info: Released builds 2.50.04D5 and higher

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-05-29
Posted by FDA: 2014-06-25
Terminated: 2021-07-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127501. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.