# FDA recall Z-2633-2017

> **Elekta, Inc.** · Class II · device recall initiated 2017-06-21.

## 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 treatme

## 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Retention of Outdated Information in an Order Set.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.

## 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

## Key facts

- **Recall number:** Z-2633-2017
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-21
- **Report date:** 2017-07-05
- **Termination date:** 2018-07-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2633-2017

## Citation

> AI Analytics. FDA recall Z-2633-2017. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2633-2017. Source: US FDA. Licensed CC0.

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