MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
FDA Recall Z-1078-2026 · Posted 2026-01-13
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Recalling FirmElekta, Inc.
Recall StatusOpen, Classified
Product CodeIYE
Date Initiated2025-12-10
Product Quantity1
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
Firm Action
On 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:
[email protected]
Tel: +1 855 6935358
https://www.elekta.com
Region Asia Pacific:
[email protected]
Tel: + 852 2891 2208
https://www.elekta.com
Japan
[email protected]
Tel: + 81 3 6722 3800
Fax: +81 3 6436 4231
https://www.elekta.com
Region China:
[email protected]
Tel : + 86 10 8012 5012
https://www.elekta.com
Region Europe:
[email protected]
Tel : + 46 8 587 254 00
https://www.elekta.com
Region Turkey, India & Middle East
[email protected]
Turkey
Tel: +90 216 444 6374
India
Tel: +1-800-103-7454
Middle East
Tel: +00 800 4000 5000
https://www.elekta.com
Root Cause
Software change control
Distribution Pattern
US Nationwide distribution in the state of TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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