Z-2633-2017Class II

MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher

Name: Z-2633-2017 MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher
Creator: Elekta, Inc.
Published: 2017-06-21
License: https://open.fda.gov/license/

Elekta Limited / initiated 2017-06-21 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ is an oncology information system used to manage workflows for... on 2017-06-21. FDA classified it as Class II and gives the reason as "Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans". 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-2633-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-21
Posted: 2017-06-27
Terminated: 2018-07-11
Recalling firm: Elekta Limited
Product: MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: 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. Users can configure MOSAIQ for Medical Oncology use, Radiation Oncology use, or the two together. It lets users: Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications. Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology. Import, view, annotate, adjust, enhance, manage and archive images. Compare radiation treatment plans and evaluate dose coverage. Design leaf plans for operation with radiotherapy treatment machines that have multileaf collimators. Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ reads actual settings from the treatment machine through the machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user. View reference images to setup treatment. MOSAIQ refers to predefined settings to help treatment machine setup, and communicates patient and machine setup instructions. Record actual delivered radiation values in an electronic chart to track treatment. MOSAIQ is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an Urgent Important Field Safety Notification letter dated June 2017. The notice informs users of the specific product and version numbers affected by the issue, and any work arounds that can be used to avoid the issue. Customers are instructed that a copy of the Important Field Safety Notice is to be kept with the most current labelling and all personnel working with the product should be made aware of the content of the letter. The customers are instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative as soon as possible but no longer than 30 days from receipt.
Quantity in commerce: 355 units
Distribution: Worldwide Distribution - US Nationwide and the countries of ANTIGUA AND BARBUDA, AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, CHEZ REPUBLIC, GERMANY, HUNGARY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, AND UK
Product codes and lots: None

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2633-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2633-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-27

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)