Elekta recalls MOSAIQ Oncology Information System and Sequencer versions 1.0+ and 6.1+ due to potential overdose from missing wedge IDs in radiation treatment plans.
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.
Elekta is recalling its MOSAIQ Oncology Information System and Sequencer software because missing wedge IDs in radiation treatment plans could cause patients to receive more radiation than intended. This risk affects radiation oncology facilities using the system for cancer treatment planning.
The system may send radiation treatment plans without including wedge-shaped radiation shields (wedges). This causes the radiation dose to exceed the planned amount, potentially increasing the risk of tissue damage in patients.
Radiation oncology clinics and hospitals using Elekta's MOSAIQ system for cancer treatment planning are most at risk. Patients receiving radiation therapy through this system could be exposed to higher doses than planned.
Check for MOSAIQ Radiation Oncology version 1.0 or higher and Multi-ACCESS version 6.1 or higher. The unique device identifiers (UDIs) listed in the recall include 858164002084, 858164002091, 858164002107, 858164002220, and 858164002237.
Verify your MOSAIQ Radiation Oncology version is 1.0 or higher and Multi-ACCESS version is 6.1 or higher.
Confirm your system's unique device identifiers (UDIs) match those listed in the recall: 858164002084, 858164002091, 858164002107, 858164002220, or 858164002237.
The recall affects radiation oncology facilities using the system, not patients directly. Patients receive treatment based on the system's plans, but the recall addresses potential errors in the planning process.
Check your MOSAIQ Radiation Oncology version (1.0 or higher) and Multi-ACCESS version (6.1 or higher), and confirm your unique device identifiers (UDIs) match the listed numbers.
The recall does not specify a remedy, so contact Elekta directly to discuss potential actions for your specific system configuration.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-0821-2019 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-0821-2019 from Elekta. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
