MOSAIQ recallZ-2591-2021 · Elekta, Inc. · initiated Sep 2, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
FDA root cause category: Software design
What the company is doing
The recalling firm issued an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" dated August 2021 via email to its consignees on 9/2/2021. Recommendations were made to the user until a fix is available.
Recall details
- Recall number
- Z-2591-2021
- Status
- Open, Classified
- Initiated by the company
- Sep 2, 2021
- Recalling firm
- Elekta, Inc.
- Quantity
- 31
- Product code
- IYE
- FDA submissions
- K183034
- Distribution
- Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, and WA. There was no military/government distribution. Foreign distribution was made to Australia, Canada, and the United Kingdom.
Product description
MOSAIQ Oncology Information System
Code information (models, lots, serial numbers)
MOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MOSAIQElekta Solutions AB · Accelerator, Linear, Medical2 recalls83 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K183034 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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