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U.S. Department of Health and Human Services

Class 2 Device Recall MOSAIQ with Particle Therapy License

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 Class 2 Device Recall MOSAIQ with Particle Therapy Licensesee related information
Date Initiated by FirmDecember 10, 2025
Date PostedJanuary 13, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1078-2026
Recall Event ID 98116
510(K)NumberK203172 K223229 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductMOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Code Information MOSAIQ v 3.10.200, and 3.1.1.0 up to and including v 3.2.3.1 with Particle Base. Software Versions: 3.10.200, 3.1.1.0, 3.1.2.0, 3.1.3.0, 3.1.3.1, 3.1.3.2, 3.1.3.3, 3.1.3.4, 3.2.0.0, 3.2.1.0, 3.2.1.1, 3.2.1.2, 3.2.1.3, 3.2.1.4, 3.2.2.0, 3.2.2.1, 3.2.3.0, 3.2.3.1 UDI-DI: 07340201500026, 07340201500071
FEI Number 1037831
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information ContactElekta Care Support
855-693-5358
Manufacturer Reason
for Recall		Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
FDA Determined
Cause 2		Software change control
ActionOn 12/10/2025 correction notices were emailed to consignees who were asked to do the following: Radiation therapists must always check the meterset values displayed on the MOSAIQ console with the value displayed on the treatment unit console. If a mismatch occurs, follow Caution 9.6 in the MOSAIQ Instructions for Use. Complete and return the acknowledgement form. Firm is working on the correction and will release a Field Safety Modification with the details as soon as possible. Elekta Regional Contact Details: Region America: Application.Support.NA@elekta.com Tel: +1 855 6935358 https://www.elekta.com Region Asia Pacific: HK.TW.Support@elekta.com Tel: + 852 2891 2208 https://www.elekta.com Japan Japan-fco@elekta.com Tel: + 81 3 6722 3800 Fax: +81 3 6436 4231 https://www.elekta.com Region China: FCO.CN@elekta.com Tel : + 86 10 8012 5012 https://www.elekta.com Region Europe: Support.europe@elekta.com Tel : + 46 8 587 254 00 https://www.elekta.com Region Turkey, India & Middle East support.rma@elekta.com Turkey Tel: +90 216 444 6374 India Tel: +1-800-103-7454 Middle East Tel: +00 800 4000 5000 https://www.elekta.com
Quantity in Commerce1
DistributionUS Nationwide distribution in the state of TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IYE
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