MOSAIQ recallZ-0686-2019 · Elekta, Inc. · initiated Dec 4, 2018
Terminated
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
If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.
FDA root cause category: Software design
What the company is doing
Elekta notified customers on about 12/04/2018 via letter titled, "Urgent Important Field Safety Notification." The letter contains recommended user action and that appropriate personnel working with the device should be advised on the content of the letter and the letter should be placed in an area accessible to all users. The letter stated that the issue will be resolved in Service Packs to MOSAIQ Releases 2.64, 2.65 and 2.70. Customers will be informed when the fix is available through a Product Bulletin. An acknowledgement Form was sent as part of the letter to be completed and returned no later than 30 days. The firm can be contacted at 408-830-8000 or 855-693-5358.
Recall details
- Recall number
- Z-0686-2019
- Status
- Terminated
- Initiated by the company
- Dec 4, 2018
- Recalling firm
- Elekta, Inc.
- Quantity
- 551 units
- Product code
- IYE
- FDA submissions
- K141572
- Distribution
- Distributed in the United States and outside of the Unites States: Algeria; Antigua and Barbuda; Argentina; Australia; Belgium; Botswana; Brazil; Canada; China; Colombia; Denmark; France; Germany; India; Indonesia; Iran; Ireland; Israel; Italy; Japan; Latvia; Lebanon; Malaysia; Mexico; Morocco; Myanmar; Netherlands; New Zealand; Norway; Peru; Philippines; Poland; Portugal; Russian Federation; Rwanda; Saudi Arabia; Senegal; Singapore; Slovenia; South Africa; Spain; Sweden; Switzerland; Taiwan; Thailand; Turkey; United Kingdom; Viet Nam
Product description
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
Code information (models, lots, serial numbers)
Software Build(s): 2.64 SP9 and higher; UDI (01)00858164002091(10)2.64.235
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MOSAIQElekta, Inc. · Accelerator, Linear, Medical3 recalls112 reports
Product lines
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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