MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Versions prior to 2.60.
- 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.
β οΈ 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:
- First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Product Codes/Lot Numbers:
Versions prior to 2.60.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0447-2016
Related Recalls
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Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.