Z-1078-2026Class II

MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

Name: Z-1078-2026 MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Creator: Elekta, Inc.
Published: 2025-12-10
License: https://open.fda.gov/license/

Elekta Limited / initiated 2025-12-10 / Open, Classified / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) on 2025-12-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1078-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-10
Posted: 2026-01-13
Recalling firm: Elekta Limited
Product: MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Product code: IYE Accelerator, Linear, Medical
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
Root cause tag: software
FDA root cause: Software change control
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
Quantity in commerce: 1
Distribution: US Nationwide distribution in the state of TX.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1078-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1078-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13

Product code IYE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)