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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: None
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Elekta, Inc.
- 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- Retention of Outdated Information in an Order Set.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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 Codes/Lot Numbers:
None
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2633-2017
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