MOSAIQ — Class II medical device recall Z-2633-2017
Terminated recall by Elekta, Inc., reported 2017-07-05, distributed nationwide. Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete
| Recall number | Z-2633-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2017-06-21 |
| Classified | 2017-06-27 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2018-07-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BH, CA, DE, ES, GB, HU, SA, SE, ZA |
| Quantity | 355 units |
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.
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Retention of Outdated Information in an Order Set.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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2633-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.