Z-0221-2015Class II

Mosaiq

Name: Z-0221-2015 Mosaiq
Creator: Elekta, Inc.
Published: 2014-11-03
License: https://open.fda.gov/license/

Elekta Limited / initiated 2014-11-03 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among... on 2014-11-03. FDA classified it as Class II and gives the reason as "A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports". 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-0221-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-03
Posted: 2014-11-15
Terminated: 2015-07-27
Recalling firm: Elekta Limited
Product: MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an Urgent Important Field Safety Notice letter to alert customers of the issue. This notice was distributed on November 3, 2014. A fix to the defect has been developed and has been released by Product Creation. For question call 408-830-8000.
Quantity in commerce: 15
Distribution: US Nationwide Distribution in the states of AZ. CO, IL, MD, MO, NY, OK, OR, PA, RI, TX, VA
Product codes and lots: MOSAIQ Release 2.60.257

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0221-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0221-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-15

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)