Recall Z-1078-2026— Elekta, Inc.

Name: FDA recall Z-1078-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-10

Class II · Ongoing

Class II FDA medical device recall by Elekta, Inc., initiated 2025-12-10. It names 2 FDA 510(k) clearances: K223229, K203172. Product: MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO). Reason: 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.

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-10
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

2 on FDA's record

K223229 — MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB·cleared 2023-02-23
K203172 — MOSAIQ Oncology Information SystemElekta Solutions AB·cleared 2020-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.