MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system use...
FDA Device Recall #Z-0821-2019 — Class II — December 13, 2018
Recall Summary
| Recall Number | Z-0821-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 13, 2018 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Elekta, Inc. |
| Location | Atlanta, GA |
| Product Type | Devices |
| Quantity | 3,950 units total (1,747 US) |
Product Description
MOSAIQ¿ Oncology Information System and Sequencer 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.
Reason for Recall
There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates.
Distribution Pattern
U.S. Nationwide distribution to the following states AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the District of Columbia and Puerto Rico.
Lot / Code Information
MOSAIQ Radiation Oncology version 1.0 and higher. Multi-ACCESS version 6.1 and higher. UDI 858164002084 858164002091 858164002107 858164002220 858164002237
Other Recalls from Elekta, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2006-2026 | Class II | Brand Name: Leksell Vantage Arc System REF: 10... | Mar 19, 2026 |
| Z-1581-2026 | Class II | Brand Name: Leksell Gamma Knife Product Descri... | Feb 18, 2026 |
| Z-1164-2026 | Class II | Brand Name: Elekta Medical Linear Accelerator ... | Dec 14, 2025 |
| Z-1339-2026 | Class II | Brand Name: Leksell GammaPlan Product Name: Ra... | Dec 12, 2025 |
| Z-1340-2026 | Class II | Brand Name: Leksell GammaPlan Product Name: Ra... | Dec 12, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.