MOSAIQ recallZ-2406-2026 · Elekta, Inc. · initiated May 21, 2026
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
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
FDA root cause category: Software design
What the company is doing
On May 21, 2026, Elekta issued a "Urgent Medical Device Notification to affected to consignees via E-Mail. Elekta asked consignees to take the following actions: 1. Please review this notification and identify if you are running the effected software version listed above. 2. If an Application Communication Time Out error message appears during a BLS plan transfer, please refer to the attached appendix. 3. Please acknowledge receipt of this notification via the Elekta Care Community or complete this form and return it to Elekta immediately upon receipt, but no later than within 30 days. 4. Please post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. 5. Advise the appropriate personnel working with this product of the content of this letter. 6. If affected product has been transferred to a different location, please ensure that location and personnel receive a copy of this notification.
Recall details
- Recall number
- Z-2406-2026
- Status
- Open, Classified
- Initiated by the company
- May 21, 2026
- Posted by the FDA
- Jun 11, 2026
- Recalling firm
- Elekta, Inc.
- Quantity
- 12 programs
- Product code
- IYE
- FDA submissions
- K223229
- Distribution
- Worldwide - US Nationwide distribution in the states of WI, FL, LA, NY, NY, NJ, KS, FL, IA, NM, TX and the countries of Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Pakistan, Panama, Poland, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.
Product description
MOSAIQ Oncology Information System
Code information (models, lots, serial numbers)
Software Version: MOSAIQ 3.2/UDI: 07340201500071
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MOSAIQ 3.2Elekta Solutions AB · Accelerator, Linear, Medical4 recalls25 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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