Elekta, Inc.: Medical Device Recall in 2026 - (Recall #: Z-1078-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 10, 2025

Date Posted: January 21, 2026

Recall Number: Z-1078-2026

Event ID: 98116

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

Status: Ongoing

Product Quantity: 1

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

Distribution Pattern:

US Nationwide distribution in the state of TX.

Voluntary or Mandated:

Voluntary: Firm initiated