Z-1869-2014Class II

MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery...

Name: Z-1869-2014 MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery...
Creator: Elekta, Inc.
Published: 2014-05-29
License: https://open.fda.gov/license/

Elekta Limited / initiated 2014-05-29 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare... on 2014-05-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1869-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-29
Posted: 2014-06-25
Terminated: 2021-07-16
Recalling firm: Elekta Limited
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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA 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 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.
Product codes and lots: Released builds 2.50.04D5 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1869-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1869-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25

Product code IYE

K123230Class IIMosaiq Oncology Information SystemImpac Medical Systems, Inc. / cleared 2012-12-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)