Elekta, Inc. recalls MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000…

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

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: 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

• FDA enforcement recordOfficial FDA database entry for Z-1078-2026
• FDA 510(k) clearance · K203172The device's official FDA premarket clearance record
• FDA 510(k) clearance · K223229The device's official FDA premarket clearance record
• FDA device classification · IYEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.5050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Elekta, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.