Z-2293-2016Class II

MOSAIQ Oncology Information System

Name: Z-2293-2016 MOSAIQ Oncology Information System
Creator: Elekta, Inc.
Published: 2016-07-15
License: https://open.fda.gov/license/

Elekta Limited / initiated 2016-07-15 / Open, Classified / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ Oncology Information System on 2016-07-15. FDA classified it as Class II and gives the reason as "It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2293-2016
Classification: Class II
Status: Open, Classified
Initiated: 2016-07-15
Posted: 2016-07-27
Recalling firm: Elekta Limited
Product: MOSAIQ Oncology Information System
Product code: IYE Accelerator, Linear, Medical
Reason for recall: It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.
Root cause tag: software
FDA root cause: Software Design Change
Action: Elekta sent Important Field Safety Notice 371-03-MSQ-001 to all customers on 7/15/2016. The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. The letter also included a response form which is to be returned to Elekta.
Quantity in commerce: 383
Distribution: Worldwide distribution. US nationwide, Antigua and Barbuda, Australia, Austria, Bahamas, Bahrain, Canada, Czech Republic, Germany, Hungary, South Africa, Spain, Sweden, Turkey, and United Kingdom
Product codes and lots: Versions 2.50.05 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2293-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2293-2016	Class II	Ongoing	Voluntary: Firm initiated	2016-08-03	2016-07-27

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)