Z-2063-2015Class II

MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for...

Name: Z-2063-2015 MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for...
Creator: Elekta, Inc.
Published: 2015-07-01
License: https://open.fda.gov/license/

Elekta Limited / initiated 2015-07-01 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports... on 2015-07-01. FDA classified it as Class II and gives the reason as "A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones". 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-2063-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-01
Posted: 2015-07-14
Terminated: 2021-09-15
Recalling firm: Elekta Limited
Product: MOSAIQ Oncology Information System 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 wherever radiotherapy and/or chemotherapy are prescribed.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an Urgent Important Field Safety Notice 371-01-MSQ-003 on July 1, 2015, to all affected customers. The notice informed users of the specific product and version numbers affected and that the problem only exists if all the following criteria is met - (1) Running Mosaiq 2.41; (2) with at least one linac equipped with an Agility 160 MLC head (Versa HD, Infinity, Axesse (EOS) or Synergy); and (3) who are treating with Stereotactic Cones. The notice also advises users of the workaround to avoid the problem. The customers were also instructed to return the Important Field Safety Notice Acknowledgment form. For questions regarding this recall call 770-670-2422.
Quantity in commerce: 74 Total (45 US)
Distribution: Worldwide Distribution - US including AZ, CA, GA, ID, IL, MO, NJ, NY, NC, OR, SC, TN, WV, and Internationally to Austria, Brazil, Bulgaria, Canada, Colombia, Germany, Israel, Italy, Japan, Mexico, Russia, Taiwan, and Venezuela.
Product codes and lots: Software Version 2.41 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2063-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2063-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-14

Product code IYE

K141572Class IIMosaiq Oncology Information SystemImpac Medical Systems, Inc. / cleared 2014-09-05

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)